Organ Manipulator Apparatus

ABSTRACT

Organ manipulation devices for atraumatically grasping the surface of an organ and repositioning the organ to allow access to a location on the organ that would otherwise be substantially inaccessible. Methods of accessing a beating heart, retracting the heart using an organ manipulation apparatus, and stabilizing a surgical target area with a stabilizer. Both the organ manipulator and stabilizer are fixed to a stationary object which may be a sternal retractor. A system for performing beating heart coronary artery bypass grafting includes a sternal retractor, organ manipulator and stabilizer.

FIELD OF THE INVENTION

The invention pertains to an apparatus for manipulating (and supportingin a retracted position) an organ such as a beating heart, methods ofusing the apparatus, a system including the apparatus and a stabilizerfor stabilizing a select area of the beating heart, and optionally, asternal retractor. The invention further pertains to method of using theapparatus for manipulating, as well as the systems.

BACKGROUND OF THE INVENTION

Coronary artery bypass grafting (CABG) has traditionally been performedwith the use of a cardiopulmonary bypass (CPB) machine to oxygenate andperfuse the body during surgery. Recently, techniques have beendeveloped to allow for performing CABG without the use of CPB bystabilizing the epicardial surface of a beating heart at the coronaryanastomotic site with a stabilizer, by contacting the surface of thebeating heart with the stabilizer to render a portion of the surfacesurrounding a target surgical site relatively motionless, to allowplacement of sutures through the graft vessel and recipient coronaryartery at the target surgical site. This procedure may be performedthrough a full sternotomy, mini-sternotomy, thoracotomy ormini-thoracotomy, or less invasively through a port provided within thechest cavity of the patient, e.g., between the ribs or in a subxyphoidarea, With or without the visual assistance of a thoracoscope.

Access to the left anterior descending (LAD) coronary artery is easilyachieved by either a sternotomy or a thoracotomy. However, the patienttropically requires bypass to multiple coronary arteries, including thecircumflex artery (CxA) on the left lateral aspect of the heart, theright coronary artery (RCA) on the right lateral aspect of the heart,and the posterior descending artery (PDA) on the back side of the heart.It is very difficult to access the CxA, RCA, and PDA without asternotomy, as the heart needs to be turned or tilted (or turned andtilted) significantly to reach its side or back, and with an intactsternum, insufficient space exists for these maneuvers. For example, theapex of the heart is generally lifted out of the body through asternotomy in order to reach the PDA. Surgeons often place the patientin a Trendelenberg position, with the operating table tilted so that thepatient's head lies lower than the feet with the patient in supineposition, in order to assist with lifting the heart up and back.

An additional challenge to beating heart surgery is that some hearts donot tolerate manipulation well from a hemodynamic standpoint. Thepotential exists with current manipulation techniques to compress theheart (e.g., by pressing it with stabilization feet) or great vessels insuch a way that hemodynamic function is compromised.

There is a need for a beating heart retraction apparatus capable ofphysically translating a beating heart from its natural resting place toa location better suited to surgical access, and then holding thebeating heart in the latter location during surgery without compressing(or otherwise deforming) the heart or great vessels in such a way thathemodynamic function is compromised.

Typically, beating heart surgery has been accomplished through a partialsternotomy using pericardial sutures to retract the heart into theproper position for surgery, and using a stabilization apparatus (e.g.,stabilizing feet) to stabilize the portion of the heart surface to beoperated on. Sometimes, surgery is performed on the properly positionedheart without using a stabilization apparatus.

However, conventional use of pericardial sutures for retraction Of abeating heart has limitations and disadvantages including the following.It is inconvenient and potentially harmful to the patient to incise thepericardium and insert sutures along cut edges of the pericardium, andthen exert tension on the sutures to move the heart together as a unitwith the pericardium. When the sutures are pulled to lift the heart(with pericardium), compressive force exerted by the pericardium on atleast one side of the heart sometimes constrains cardiac contraction andexpansion.

There are three distinct stages involved in preparing an artery (on anorgan) for anastomosis:

gross manipulation: the organ is physically translated from its naturalresting place to a location better suited to surgical access;

artery presentation: the target artery on the organ is identified andthe position of the organ is finely adjusted so that the target arteryis approachable; and

artery stabilization: the target artery and surrounding tissues areimmobilized. allowing fine surgical techniques on very small features.

One class of the stabilization devices commonly used to stabilize atarget portion of a heart surface (a portion on which surgery is to beperformed) are the stabilization devices that comprise rigid ((T-shapedor linear) structures lined with suction cups, such as those describedin the article Borst, et al., “Coronary Artery Bypass Grafting WithoutCardiopulmonary Bypass and Without Interruption of Native Coronary FlowUsing a Novel Anastomosis Site Restraining Device (“Octopus”), J. of theAmerican College of Cardiology, Vol. 27, No. 6, pp. 1356-1364, May 1996,and in U.S. Pat. No. 6,334,843. The stabilization devices described aremarketed by Medtronic, Inc. and are known as “Octopus” devices.

It has been proposed to use such an Octopus device to assist inrepositioning the heart into a desired position for surgery (by holdingthe retracted heart in this position), as well as to stabilize a portionof the heart's surface following retraction (gross movement) of theheart. See, for example, U.S. Pat. No. 6,334,843 and PCT InternationalApplication WO97/10753 (by Medtronic, Inc.) entitled “Method andApparatus for Temporarily Immobilizing a Local Area of Tissue,”published Mar. 27, 1997, especially with reference to FIG. 33 thereof.However, no conventional Octopus device can support a beating heart withadequate compliance to allow normal heart beating movement, and insteadeach conventional Octopus device would exert compressive or twistingforce on at least one side of the beating heart, thereby constrainingcardiac contraction and expansion. Also, one of the small-diametersuction cups of a conventional Octopus device would be too small toreliably grip (and support) the heart without causing trauma to theheart surface. Thus, in order to reliably (but atraumatically) retractand support the heart in the retracted position, many small-diametersuction cups (supported on a rigid frame which frame is itself rigidlysupported) need to exert suction simultaneously on the heart, whichexacerbates the problem of constrained cardiac contraction and expansiondue to the exertion of compressive or twisting force on the heart.

U.S. Pat. No. 5,799,661, which issued Sep. 1, 1998 to Boyd, et al. (andassigned to Heartport, Inc.) describes (with reference to FIGS. 33A-33C)a suction cup manipulator on a long shaft. The suction cup is to beattached to an arrested heart by suction, and the device is thenmanipulated to move the heart around in the chest cavity. A vacuum isapplied to the cup to provide suction, and the vacuum is said preferablyto have a value not less than −150 mmHg (to avoid tissue damage). Thesuction cup is made of “a soft, flexible elastomeric material such assilicone rubber, has a diameter of approximately 12 mm to 50 mm, and hasa textured, high friction distal surface (for gripping the heart). Thehigh friction can be achieved by a pattern of bumps or an absorbent highfriction material (such as nonwoven polyester fabric). A disadvantage ofthe bumps is that they would likely cause trauma to the organ beingmanipulated (even with a vacuum in the preferred range).

U.S. Pat. No. 5,799,661 suggests without explanation that the suctioncup is flexibly mounted to the distal end of a rigid shaft, but it isapparent from FIGS. 33A-33B that this simply means that the cup itselfhas some flexibility so that the cup can bend relative to the rigidshaft. U.S. Pat. No. 5,799,661 does not teach attaching the suction cupto the shaft by a joint which provides limited freedom to translatealong a first axis and/or full (or at least limited) freedom to rotateabout the first axis, but no significant freedom to translate indirections perpendicular to the first axis. Thus, the suction cupapparatus described in U.S. Pat. No. 5,799,611 is useful only to retractan arrested heart; not a beating heart or other moving organ since thesuction cup apparatus of U.S. Pat. No. 5,799,611 does not havecompliance to allow for normal organ movement such as a heart beat, andwould instead exert compressive or twisting restraint forces on at leastone side of the moving organ, thereby constraining cardiac contractility(contraction and expansion) or other normal organ movement.

U.S. Pat. No. 5,782,746, issued Jul. 21, 1998, discloses an annularsuction device for immobilizing part of the surface of a heart duringsurgery. Although the device is said to allow the heart to beat in a“relatively normal” manner during surgery, “the device is rigidlymounted to a fixed mounting structure during surgery, and thus neitherthe device nor the part of the heart surface which it immobilizes wouldhave freedom to move significantly relative to the mounting structureduring surgery. The reference suggests positioning the device on theheart, applying vacuum to the device to cause it to exert suction on theheart, then moving the device to “partially” raise the heart, and thenrigidly mounting the device to the fixed mounting structure so that thedevice supports the “partially raised” heart during surgery.

WO 97/26828 (Gentilli) discloses a laparascopic-endoscopic surgicalinstrument for grasping and handling parenchymatous and cavum organs.The instrument has a rigid tube with a suction cup provided at theproximal end of the tube. The suction cup is pivotally connect to theend of the tube by a flexible section and stray wires are axiallyprovided along the rigid tube and connected to the suction cup so theorientation of the suction cup can be changed by operating the wires atthe distal end of the rigid tube. The rigid tube is connected to avacuum source at its distal end for application of vacuum to the suctioncup. There is no disclosure as to use of the device for manipulating aheart. More importantly, there is no provision for allowing rotation ofthe organ once it has been grasped by the suction cup, nor is there anyprovision for even allowing axial movement of the organ once it has beengrasped by the suction cup. Only pivoting of the suction cup is providedfor and the purpose of such pivoting appears to be for remotelycontrolling the orientation of the suction cup to align it with thetarget organ before engaging the organ. Additionally, the flexiblemember biases the suction cup toward axial alignment with the rigidtube.

SUMMARY OF THE INVENTION

The present invention pertains to improved methods, apparatus andsystems for retraction (gross movement) of a beating heart or otherorgan into a desired position and orientation to allow surgery to beperformed on the organ. When the organ has been retracted (in accordancewith the invention) into a desired position and orientation, astabilizer can be used to stabilize a portion of the organ's surface onwhich surgery is to be performed. However, such tissue stabilizationproducts cannot duplicate the function of the inventive apparatus.Retraction requires lifting and usually rotation of the organ. Devicesdesigned specifically for tissue stabilization are not well suited tothose motions.

The apparatus of the invention differs in purpose and form fromconventional tissue stabilization devices. The purpose of the inventiveapparatus is to move an organ grossly from one position to another andmaintain the organ in a desired gross position (without significantlyconstraining cardiac contraction and expansion or significantlyeffecting the contractility of the beating heart). The inventiveapparatus is not designed to stabilize specific areas of the organ. Theshape and nature of the suction member or members of the inventiveapparatus differ from the suction cups of conventional tissuestabilization devices in the need to accommodate different anatomy. Forexample, the inventive suction member can be larger than a suctionapplicator of a conventional tissue stabilization device. Also, sincethe inventive apparatus exerts suction over a larger surface area oforgan tissue, the required pressure differential can be less than thatrequired by conventional tissue stabilization devices. The low-pressuredifferential has a clinical benefit in that the potential for creationof hematomas is lessened.

A key difference between the inventive apparatus and both conventionalapparatus for tissue stabilization and conventional apparatus for organretraction is that the inventive apparatus provides system compliancethat allows the target organ to maintain substantially normal motion(e.g., normal contraction and expansion in the case that the organ is abeating heart). In the case of a beating heart, this compliance providesdistinct clinical value by lessening the negative impact of manipulationon the contractility of the beating heart, and ultimately, thehemodynamics of the cardiac output.

Accordingly, provided herein are organ manipulation apparatus whichinclude at least one suction member configured to exert sufficient forceon an organ to move the organ when the suction member is placed againstthe organ, a relative negative pressure is established in a spacebetween the suction member and the organ, and tile suction member ismoved. A support structure adapted to be substantially rigidly fixed toa relatively immovable object is provided, and a suspensioninterconnects the at least one suction member and the support structure,in a ways that allows at least a limited amount of rotation of the atleast one suction member with respect to the support member toaccommodate natural movements of the organ.

The suspension of an apparatus according to the present invention mayfurther allow a limited amount of translation of the at least onesuction member, along an axis of a suction member, with respect to thesupport structure

In several arrangements, a suction member is provided with asubstantially rigid shaft or tube extending therefrom, and thesuspension includes a roller rotatably mounted in a base member. Theroller has an axis of rotation and a bore substantially perpendicular tothe axis of rotation, in or through which the substantially rigid shaftis mounted. The base member may be rotatably mounted to the supportstructure.

At least one variation of the base member includes a biased retentionmechanism, with the cooperating support structure having a retentionhead at an end portion thereof, which is insertable into the base memberto form a snap fit with the retention mechanism.

A biasing member may be mounted so as to bias the suction member shaftrelative to the roller in a direction of translation. In at least oneexample, the biasing member is a spring coupled between a stop member onthe shaft and the roller.

In other variations, the substantially rigid shaft is fixed with respectto the roller With respect to translation of the substantially rigidshaft relative to the roller, in a direction along a longitudinal axisof the substantially rigid shaft. In these variations, at least aportion of the suspension base member is flexible, thereby allowinglimited amounts of translation of the suction member and the roller withrespect to the support structure.

The base member may be formed as a clevis, wherein a first end of theroller is inserted in a first arm of the clevis and a second end of theroller is inserted in a second arm of the clevis.

The base member of the suspension may be rotatably mounted to thesupport structure.

Although the substantially rigid shaft in some embodiments is fixed withrespect to translation relative to the roller, it may be rotatablymounted with respect to the roller, allowing the suction member torotate relative to the roller.

A connector may be fluidly connected to the substantially rigid shaft,which is adapted to connect with a source of vacuum. At least a portionof the connector is rotatable with respect to the substantially rigidshaft.

The suspension may comprise an elastomeric tubular member extending fromthe suction member which is adapted to be connected with the supportstructure. The elastomeric tubular member allows a limited amount oftranslation of the suction member, along an axis of the suction member,with respect to the support structure. First and second stops may becoaxially mounted with respect to tile elastomeric tubular member, todefine a mounting section therebetween. A hook member adapted to snapfit over the mounting section, interconnects the suction member and thesupport structure, and allows rotation of the suction member withrespect to the hook member.

In another variation, a spring is positioned Within a lumen of theelastomeric tubular member to help prevent kinking.

A flexible tubular member that fluidly connects the suction member witha source of negative pressure may be provided within a substantiallyrigid tubular member which functions as a support structure or supportarm. At least a portion of the flexible tubular member may be pleated.

Another example of a suspension according to the present inventionincludes a ball having a first passage therethrough and a socketpartially constraining the ball but allowing rotation thereof withrespect to, the socket, with a substantially rigid tubular member orsupport arm passing through the first passage. The ball and socketfluidly connects the suction member with the substantially rigid arm viaan opening in the substantially rigid tubular member.

The support structure of the manipulation apparatus ma) include anarticulating arm have a flexible state and a rigid state. Thearticulating arm mal include a cable; a plurality of depression disksand balls alternatively threaded over the cable, each of the depressiondisks having a pair of concave surfaces adapted to engage a pair of theballs. and a tensioning mechanism adapted to apply tension to the cable.The balls and compression disks are compressed against one another uponapplication of tension to the cable and the articulating arm assumes therigid state.

The concave surfaces of the depression disks are harder than the ballsin several embodiments. The depression disks may included recesses in orprotrusions from the concave surfaces.

The depression disks may be formed to have concave surfaces that have acentral portion formed of a first material that is softer than a secondmaterial which forms an outer portion of the concave surfaces. The firstmaterial protrudes slightly from the second material, and the balls areformed of a material that is harder than the first material.

The support structure of the manipulation apparatus may alternativelyinclude a substantially rigid shaft, a substantially rigid, curved arm;or a substantially rigid tubular member.

Various suction members are provided, including a suction membercomprising a foam cup having an inside surface and an outside skinnedsurface. A peripheral of the cup is folded over so that the skinnedsurface is adapted to contact an organ and form a seal therewith.

Another suction member comprises a silicone cup having an inner liningof open cell foam, wherein the inner lining further comprises a skin ata peripheral thereof.

Yet another suction member includes a cup having internal groovesadapted to apply negative pressure to a surface of an organ even if theorgan is sucked inside the cup to contact an inner surface thereof.

A suction member may be provided with a restraint member, that restrainsthe organ and defines a vacuum baffle chamber between it and the topinner surface of the cup.

Numerous other examples of suction members are described in detailherein, for use in various organ manipulation apparatus as describedherein.

An organ manipulation apparatus is described which includes a suctionmember configured to exert sufficient force on an organ to move theorgan when the suction member is placed against the organ, a relativenegative pressure is established in a space between the suction memberand the organ, and the suction member is moved; a support structureadapted to be inserted through a small opening in a body of a patient; acoupling member into which the support structure is fitted afterinsertion of the support structure through the small opening; and aflexible suspension interconnecting the suction member and the couplingmember. The coupling member may be rotatable with respect to the supportstructure after coupling the support structure and the coupling member.A binding member math be proved to prevent advancement of the supportstructure further into the body once the support structure has beenpositioned as desired.

A surgical method performed on a beating heart is disclosed to includethe steps of: applying a suction member of a manipulation device to asurface of the heart; creating suction between the suction member andsurface of the heart; moving the suction member to retract the heartinto a position that provides access to a surgical site that would bedifficult or impossible to access without retraction; connecting thesuction member with a compliance mechanism attached to a support arm.and fixing the support arm with respect to a stationary object, whereinthe compliance mechanism permits at least limited translation of theheart and suction member with respect to the support arm.

The suction member and heart are rotatable with respect to the supportarm, even after fixing the support arm.

The method may further include the steps of contacting a surgical targetarea on the heart with a stabilizer in the vicinity of the surgicaltarget to stabilize the surgical target; and performing a surgicalprocedure on the surgical target.

Still further, the stabilizer may be fixed to a stationary object priorto performing a surgical procedure. The contact by the stabilizer mayinclude contacting with a suction stabilizer and applying suction tograsp tissue in the vicinity of the surgical target, and/or applyingmechanical pressure to tissue in the vicinity of the surgical target.

Still further, a surgical method performed on a beating heart isdescribed to include the steps of: providing a manipulation devicehaving a suction member, a support arm, and a compliance mechanisminterconnecting the suction member and support arm and permitting atleast limited translation and rotation of the suction member withrespect to the support arm; applying the suction member of themanipulation device to a surface of the heart; creating suction betweenthe suction member and surface of the heart; moving the suction memberto retract the heart into a position that provides access to a surgicalsite that would be difficult or impossible to access without retraction;and fixing the support arm with respect to a stationary object, whereinthe compliance mechanism permits at least limited translation androtation of the heart and suction member with respect to the supportarm.

This method may further include the steps of: contacting a surgicaltarget area on the heart with a stabilizer in the vicinity of thesurgical target to stabilize the surgical target; and performing asurgical procedure on the surgical target.

Further, the stabilizer may be fixed to a stationary object prior toperforming a surgical procedure. The contacting with a stabilizer may beperformed with a suction stabilizer or a mechanical stabilizer.

Another disclosed surgical method performed on a beating heart comprisesthe steps of: providing a manipulation device having a suction member, asupport arm, and a suspension interconnecting the suction member andsupport arm and permitting at least limited movement of the suctionmember with respect to the support arm; accessing the beating heart of apatient; contacting the suction member of the manipulation device to asurface of the heart; creating suction between the suction member andsurface of the heart so that the suction member grasps the surface ofthe heart; moving the suction member to retract the heart into aposition that provides access to a surgical site that would be difficultor impossible to access without retraction. contacting tissue of theheart at or near the surgical site with a stabilizer and stabilizing thesurgical site; and performing a surgical procedure at the surgical site.

Further, the method may include the step of fixing the support arm withrespect to a stationary object after the step of moving the suctionmember to retract the heart.

The suspension permits at least limited translation and rotation of theheart and suction member with respect to the support arm.

The method may further include applying suction through a contact memberof the stabilizer contacting the heart tissue to perform thestabilization of the surgical site, and the stabilizer may be fixed to astationary object to maintain the stabilization. Alternatively, amechanical stabilizer may be applied to accomplish the stabilization.

Still further, a method performed on a beating heart is described toinclude the steps of: accessing the beating heart of a patient;contacting a suction member of an organ manipulation device to a surfaceof the heart; creating suction between the suction member and surface ofthe heart so that the suction member grasps the surface of the heart;moving the suction member to retract the heart into a position thatprovides access to a surgical site that would be difficult or impossibleto access without retraction; contacting tissue of the heart at or nearthe surgical site with a stabilizer and stabilizing the surgical site;and performing a surgical procedure at the surgical site.

The method may further include the step of fixing or connecting asupport arm to the suction member and Fixing the support arm withrespect to a stationary object after the step of moving the suctionmember to retract the heart.

The suspension preferably permits at least limited translation androtation of the heart and suction member with respect to the supportarm.

A system for performing beating heart coronary artery bypass grafting isdisclosed to include: an organ manipulation device having a suctionmember configured to exert sufficient force on the beating heart to movethe beating heart when the suction member is placed against a surface ofthe heart, a relative negative pressure is established in a spacebetween the suction member and the heart, and the suction member ismoved; a support structure adapted to be substantially rigidly fixed toa relatively immovable object; and a suspension interconnecting thesuction member and the support structure, the suspension allowing atleast a limited amount of rotation of the suction member with respect tothe support member to accommodate natural movements of the beatingheart; a stabilizer device having at least one contact member adapted tocontact the surface of the beating heart at or adjacent a location wherean anastomosis is to be performed; and a sternal retractor, wherein thesupport arm and the stabilizer are adapted to be fixed to the sternalretractor.

The suspension of the organ manipulator may further allow a limitedamount of translation of the suction member, along an axis of thesuction member, with respect to the support structure.

A system for performing beating heart coronary artery bypass grafting isprovided to include: an organ manipulation device having a suctionmember configured to exert sufficient force on the beating heart to movethe beating heart when the suction member is placed against a surface ofthe heart, a relative negative pressure is established in a spacebetween the suction member and the heart, and the suction member ismoved; a support structure adapted to be substantially rigidly fixed toa relatively immovable object; and a suspension interconnecting thesuction member and the support structure, the suspension allowing atleast a limited amount of rotation of the suction member with respect tothe support member to accommodate natural movements of the beatingheart; and a stabilizer device having at least one contact memberadapted to contact the surface of the beating heart at or adjacent alocation where an anastomosis is to be performed.

The suspension of the organ manipulator may further allow a limitedamount of translation of the suction member, along an axis of thesuction member, with respect to the support structure.

These and other objects, advantages, and features of the invention willbecome apparent to those persons skilled in the art upon reading thedetails of the apparatus, systems and methods as more fully describedbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of an example of an organ manipulationapparatus mounted to a sternal retractor according to the presentinvention.

FIG. 1B is a partial perspective view of the retractor of FIG. 1A with atissue stabilizer mounted thereto to be employed in a procedure with anorgan manipulation apparatus according to the present invention.

FIG. 1C is a side view of an example of a tissue contact member thatemploys suction and which may be substituted for the tissue contactmember of the stabilizer in FIG. 1B.

FIG. 1D is a perspective view of the retractor shown in FIG. 1A having atissue stabilizer mounted thereto.

FIG. 1E is an enlarged perspective view of the stabilizer and mountingmechanism shown in FIG. 1D.

FIG. 2A is a sectional view of one example of a suction member accordingto the present invention.

FIGS. 2B-2E are sectional views of various stages of making the suctionmember of FIG. 2A.

FIG. 3 is a sectional view of another example of a suction memberaccording to the present invention.

FIG. 4 is a sectional view of an example of a suction member having atissue restraint member therein.

FIG. 5 is a sectional view of another example of a suction member havinga tissue restraint member therein.

FIG. 6 is a sectional view of a suction member that includes grooves tomaintain an open vacuum flow path upon contact of the suction member andapplication of vacuum to tissue.

FIG. 7A is an impermeable layer with a hole pattern formed therein.

FIG. 7B is a top view of the impermeable layer with a hole patternformed therein of the suction member of FIG. 6.

FIG. 8A is a sectional view of a suction member having a thin skirtperipherally located at the opening of the suction member.

FIG. 8B is an enlarged view of the portion of FIG. 8A defined by circle1, and showing the deformation that the thin skirt undergoes uponcontacting an organ.

FIG. 9A is a sectional view of another example of a suction memberhaving a thin skirt.

FIG. 9B is a top view of the impermeable material layer of the suctionmember of FIG. 9A, showing the distribution of through holes throughwhich vacuum is applied.

FIG. 10A is a sectional view of another example of a suction memberaccording to the present invention.

FIG. 10B is a bottom view of the suction member of FIG. 10A.

FIG. 11 is a sectional view of another example of a suction memberaccording to the present invention.

FIG. 12A is a sectional view of another example of a suction memberaccording to the present invention.

FIG. 12B is a sectional view of another example of a suction memberaccording to the present invention.

FIG. 12C is a bottom view of the suction member referred to in FIG. 12B.

FIG. 12D is a sectional view of another example of a suction memberaccording to the present invention.

FIG. 12E is a bottom view of the suction member referred to in FIG. 12D.

FIG. 13A is a side sectional view of another example a suction memberaccording to the present invention.

FIG. 13B is a view of the suction member of FIG. 13A in contact with theapical portion of a beating heart.

FIG. 13C is a cross-sectional view of the suction member of FIG. 13A,taken along line 13-13.

FIG. 14A is a perspective view of a suspension connected to a suctionmember according to the present invention.

FIG. 14B is a partial sectional view of a suction member having asubstantially C-shaped compliant seal.

FIG. 15A is a top view of a suction member according to the presentinvention.

FIG. 15B is a side view of the suction member shown in FIG. 15A.

FIG. 15C is an end view of the suction member shown in FIG. 15A.

FIG. 15D is a sectional view of the suction member shove in FIG. 15A,taken along line 15D-15D.

FIG. 16A is an exploded view of a support arm (partial) and asuspension.

FIG. 16B is an exploded view of the suspension shoved in FIG. 16A.

FIG. 17A is a top view of another example of a suspension according tothe present invention.

FIG. 17B is a side view of the suspension shown in FIG. 17A attached toa suction member.

FIG. 17C is a perspective view of a roller portion of the suspensionshown in FIG. 17A.

FIG. 18A is a top view of another example of a suspension according tothe present invention.

FIG. 18B is a view of the suspension shown in FIG. 18A attached to asuction member.

FIG. 19A is a view of a suspension and suction member which are readilydetachable from a support arm.

FIG. 19B shows a readily releasable connector for interconnecting asupport structure with the suspension and suction member.

FIG. 20 shows another example of an organ manipulation apparatusaccording to the present invention.

FIG. 21 shows a further example of an organ manipulation apparatusaccording to the present invention.

FIG. 22 shows still a further example of an organ manipulation apparatusaccording to the present invention.

FIG. 23 is a partial view of an organ manipulation apparatus using ananti-kinking vacuum line.

FIG. 24 shows another example of a suspension according to the presentinvention.

FIG. 25 is an example of an organ manipulation apparatus that iswell-suited for intercostal insertion of the supporting shaft.

FIG. 26A is a sectional view of a binding member in a freely slidingposition.

FIG. 26B is a sectional view of the binding member of FIG. 26A, but inthe binding position.

FIG. 27A is an exploded view of a portion of an organ manipulationapparatus according to the present invention.

FIG. 27B is an assembled view of the portion shorn in FIG. 27A.

FIG. 27C shows a clevis which forms a portion of the suspension inassembly and which connects the suction member to a support structure.

FIG. 27D shows the portion of FIG. 27B having been attached to and usedto position a beating heart, and bringing a support structure intoposition to relatively fix the positioning.

FIG. 27E shows the support structure of FIG. 27D having been connectedwith the portion of FIG. 27B.

FIG. 28A shows an example of a depression disk that may be used in thearticulating arm shown in FIG. 1.

FIG. 28B shows an example of a ball that may be used in the articulatingarm shown in FIG. 1.

FIG. 28C shows another example of a depression disk that may be used inthe articulating arm shown in FIG. 1.

FIG. 28D shows another example of a depression disk that may be used inthe articulating arm shown in FIG. 1.

FIG. 28E shows another example of a depression disk that may be used inthe articulating arm shown in FIG. 1.

FIG. 29 is a perspective view of a sternal retractor to which an organmanipulation device may be mounted according to the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Before the present apparatus and methods are described, it is to beunderstood that this invention is not limited to particular structuresdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present invention will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either. neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, the preferred methodsand materials are now described. All publications mentioned herein areincorporated herein by reference to disclose and describe the methodsand/or materials in connection with which the publications are cited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “and”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “asuction member” includes a plurality of such suction members cells andreference to “the vacuum line” includes reference to one or more vacuumlines and equivalents thereof known to those skilled in the art, and soforth.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such publication by virtue of prior invention.Further, the dates of publication provided may be different from theactual publication dales which may need to be independently confirmed.

Referring to FIG. 1A, a manipulation apparatus 10 is provided to retractheart 2 to a position suitable for performing surgery thereon, and toretain heart 2 grossly in the retracted position, while at the same timeallowing limited amounts of freedom to move so as not to adverselyeffect the pumping action of the heart 2 as it continues to beat.Manipulation apparatus 10 includes a suction member 20 which is adaptedto be fluidly connected with a source of vacuum and is further adaptedto contact the surface of the heart 2 and engage the heart 2 withapplication of vacuum thereby attaching to it with an attachment forcesufficient to retract the heart as shown in FIG. 1 and to withstand theadditional forces applied to it by the beating movements of the heart.Manipulation apparatus 10 further includes a support structure, memberor arm 40 which may be rigidly fixed to a stationary member, such as asternal retractor 4, operating table, ceiling, floor or other relativelyimmovable object, and a suspension 30 which connects suction member 20with support arm 40 thereby grossly positioning the suction member whilestill allowing limited amounts of movement of the suction member withrespect to the relatively fixed support arm 40. Thus, suspension 30performs a very important function in allowing the heart to contract,twist, and otherwise move in a substantially normal fashion, so as notto restrict the contractility and cardiac output of the beating heartwhile it is in a retracted position.

In this example, a full median sternotomy, has been employed, with thechest cavity being opened at the site of the sternal incision usingsternal retractor 4. This approach allows a portion of the heart toactually be lifted up out of the chest cavity for better access tosurgical sites, while still allowing the heart to beat relativelynormally, as described above. However, the present invention may also beused in procedures using other types of access to the heart, such as apartial sternotomy, sub-xyphoid incision, mini-sternotomy, thoracotomyor mini-thoracotomy, or less invasively through a port or stab woundprovided within the chest cavity of the patient, e.g., between the ribsor in a subxyphoid area, with or without the visual assistance of athoracoscope.

In practice, a retractor, such as retractor 4, for example, (FIGS. 1Aand 1D) is inserted into a sternotomy incision such that a pair ofopposing blades 414 and 416 each having one or more channels or engagingmembers 402 adapted to engage opposite sides of an access incision arepositioned against the opposite sides of the incision. A drivemechanism, such as a rack and pinion drive mechanism 424 or other wellknown drive mechanism is used to drive the blades, and thus the sternumapart. In the example shown, rotation of handle 424 a causes advancementof the pinion over the rack teeth 424 b of the rack formed on thecrossbar 405 of the rack and pinion mechanism 424, thereby driving theopposing blades 414 and 416 apart and causing engaging members 402 tocorrespondingly force the incision open to provide access to the desiredsurgical site.

In a sternal approach to the heart, engaging members 402 are adapted toengage each side of the incised sternum to reliably hold and engage thesternum as the sternum is forced open to expose the thoracic cavity andultimately the heart. Engaging members 402 may be generally in the formof a channel or the like, and have a U-shape, curved shape, or othershape suitable for engaging the incised sternum. Typically, the drivemechanism is constructed to spread the opposing blades apart in agenerally parallel fashion, however, the parting motion may also have asignificant curvilinear or angular component as well. Also, theretractor may be one which spreads the opposite sides of the rib cage sothat they are level with one another in the open configuration, oralternatively, they may be offset, such that one side of the rib cage oropening is higher than the other side in the open configuration.

In addition to engaging members 402, retractor 4 may incorporate a widevariety of additional features which enhance the performance of theretractor system. For example, one or both of blades 14 and 16 may havemounting features to which various instruments used during the procedurecan be secured. When an organ manipulation apparatus 10 is to be securedto a stationary object, retractor 4 can serve as one example of astationary object. It is critical to minimize or substantially eliminatethe amount of flex and motion attributable to a support structure, suchas support arm 40, to fix the desired location of gross positioning ofthe heart, from which location, suspension 30 will allow limited amountsof movement of suction member 20 and heart 2 thereabout. When astabilizer is to be secured to retractor 4 during a beating heartsurgical procedure, it is critical to minimize or substantiallyeliminate the amount of flex and motion attributable to each componentand each connection between each component, from the component engagingthe beating heart to the component which provides the sternalattachment. To this end, the engaging features 402 which engage thesternum are preferably part of a unitary platform blade structure whichalso includes mounting features to which an organ manipulationapparatus, stabilizer and other instruments can be mounted. Since themounting features and the sternal engaging features are part of the samecomponent, and therefore there is no mechanical connection between thetwo, the stability of an attached instrument against the forces of abeating heart is greatly improved.

In the example shown in FIGS. 1A, 1B, 1D and 29, each of first andsecond platform blades 414 and 416 include mount features in the form ofrails 418. Rails 418 allow one or more instruments to be positioned atany desired location along the operable length of the rail.Additionally, crossbar 5 is dimensioned so that one or more instrumentsmay also be fixed to it, to provide still greater flexibility inpositioning instruments in the most desirable locations, from both theperspective of the functioning of each particular instrument, as well asthe perspective of maximizing access space and visibility that isavailable to the surgeon. Preferably, rails 418 are oriented in adirection generally perpendicular to the direction of separation, inthis case perpendicular to crossbar 405. The rails may be recessedfeatures within the body of platform blades 414 and 416. Morepreferably, the mounting rails extend upwardly from the body of platformblades 414 and 416, and extend over at least a portion of the length ofthe platform blade. Rail 418 may have a top portion and a bottom portionhaving a narrowed region adjacent the top portion. For example, rail 418may have a T-shaped cross-section. The T-shaped configuration has a topportion and a narrowed portion, thus forming mounting tabs 418 m whichcan be gripped by a number of appropriately constructed mounts. Rail 418rail may be straight, cured, or a combination of straight and curvedportions. Further details regarding the construction and use of aretractor such as that shown in FIG. 28 can be found in U.S. Pat. No.6,331,158, which is hereby incorporated in its entirety by referencethereto.

When the chest is opened by a median sternotomy as described above, itis possible to gain access to all chambers and surfaces of the heart.The coronary vessels (which are primary target sites in CABG procedures)are surface vessels, only occasionally dipping into the myocardium,making them accessible for CABG without opening the heart. In order toaccess coronary arteries on the posterior or inferior surfaces of theheart, however, the heart must be lifted, e.g., such as in a mannershown in FIG. 1A. A beating heart CABG procedure requires that the heartbe lifted and held in such a way as to minimize any detrimental effectson contractility of the heart, so as to continue substantially normalcardiac output and prevent ischemia, fibrillation and a number ofrelated problems.

Once the heart has been adequately exposed according to the aboveprocedure and is ready to be grossly repositioned, an organ manipulationapparatus 10 is maneuvered to position suction member 20 into contactwith a surface of the heart for attachment thereto. With the arrangementshown in FIG. 1A, organ manipulator 10 is preferably fixed to astationary object such as retractor 4 (e.g. to a rail 418 or to crossbar5 as shown) prior to contacting suction member 20 to the heart 2 if thesituation permits. Alternatively, the suction member 20 may be used tograsp the heart ( in a manner described below) prior to fixing the organmanipulator and used to move the heart at least a portion of thedistance toward the desired gross positioning location, and then theorgan manipulator 10 can be fixed to a stationary object. In eithercase, the support arm 40 of the organ manipulator 10 shown in FIG. 1A ismaintained in a flexible slate to allow greater maneuverability duringmanipulation of the heart 2 and/or attachment of the support arm 40 tothe suction member after gross positioning of the heart 2.

In the example of FIG. 1A, suction member 20 is attached to the apex ofthe heart, which is a region that is commonly used for manipulation ofthe heart so as help minimize any negative effects on the chamber walls.However, the present invention is not limited to attachment to the apex,as other surface locations of the heart may be grasped by suction member20 from which vantage point the organ manipulation apparatus is used toreposition the heart. Once suction member 20 has been positioned asdesired and contacts the surface of the heart 2, suction is applied tosuction member 20 through suction line 7 whereby the suction membergrasps the surface of the heart with a force sufficient to move theheart by movement of the suction member, without release, detachment orbreaking of the vacuum seal that is formed between suction member 20 andthe heart 2. Typically, the suction is applied by a suction accumulator9 and the amount of vacuum applied is controlled by a suction flowregulator 8.

The organ manipulator 10 is moved so as to pull the heart 2 to a grossposition that allows the surgeon access to one or more desired surgicallocations. When the heart has substantially reached the desiredorientation of the gross positioning, the support arm 40 of organmanipulator is fixed in its present relative position, thereby forming aportion of a relatively stationary support structure for the suctionmember 20. Thus, support arm 40 remains relatively motionless, whilesuspension 30 allows limited amounts of movement of suction member 20(and thus, also the heart 2) relative to the stationary support arm 40,and thereby does not significantly impede the normal beating of theheart or the cardiac output resultant therefrom.

After fixing the gross position of the heart 2 as described above, atissue stabilizing instrument may be employed to stabilize an area ofthe beating heart Which includes a target site for a surgical procedureto be performed. For example, a tissue stabilizer may be used forstabilization of a beating heart during a coronary artery bypass graft(CABG) procedure in which the bypass of a narrowed or blocked vessel isperformed without application of cardioplegia to the patient and withoutcardiopulmonary bypass. The tissue stabilizer enables the contacting ofthe heart and relative stabilization at and in the surrounding area ofthe portion of the heart contacted to make it possible to performdelicate surgical tasks in that area.

The tissue stabilizer may, be mounted to a relatively stationary object,(e.g., at a location on one of the rails 418 that provides advantageouspositioning of the stabilizer 140, e.g., see FIG. 1B), and is thenmanipulated so as to bring at least one component of the stabilizerassembly into contact with the beating heart 2 adjacent the targetsurgical site (e.g., site of the anastomosis). The surgeon typicallyapplies a stabilizing force to the beating heart via the stabilizerassembly, as by applying mechanical pressure through a contact member incontact With the heart tissue in the case of a mechanical stabilizer, oras by applying suction through a suction member in contact with theheart tissue, in the case of a suction stabilizer, until the desiredstabilization is attained, and secures the stabilizer assembly in afixed orientation to maintain the stabilizing force against the beatingheart.

The positioning and fixation of the stabilizer assembly substantiallyeliminates movement of the heart in the target area of surgery to beperformed (such as an area in which an anastomosis is to be performed,for example), thereby facilitating the surgeon's placement of suturesand related procedural requirements in performing the anastomosis (orother surgical procedure).

Although, in this example, the organ manipulator 10 and tissuestabilizer are most advantageously employed in combination with sternalretractor 4 used to provide an opening in the chest for direct access tothe heart, it would be apparent to one of ordinary skill in the art thatone or both of the instruments could be employed separately from aretractor. They are nonetheless adapted to be mounted to a retractor toprovide a desirable base of stability. However, other objects offixation could be utilized if necessary, as known in the art. Further,other types of retractors than a sternal retractor might be employed toachieve access to the heart, and such other retractors (e.g., retractorused in thoracotomy, and other rib separators) could also serve as abase to which the present instruments could be fixed.

Further, the instruments could be advantageously used for theirstabilization capabilities in a stopped heart procedure, includingprocedures employing cardiopulmonary bypass. However, the presentinstruments are particularly advantageous in beating heart procedures.Although the present instruments may access and stabilize the beatingheart in a number of surgical contexts involving various incisions andsurgical approaches to the heart as are known in the art, theinstruments described herein are most advantageously employed in CABGprocedures where the heart is accessed through only one or two minimallyinvasive incisions in the chest. Particularly, methods involving asternal retractor are described as well as a method involvingintercostal access or access through a stab wound or other smallincision.

The anastomosis procedure performed during a CABG operation is adelicate and exacting procedure which requires the installation of veryfine sutures (or other connector(s)) around the entire perimeter of thesource vessel or graft to attach it to the target vessel in a mannerthat is substantially leak-proof, for the immediate commencement ofdelivery of blood to the heart via the surgically altered pathwayachieved by the procedure. For this reason, effective stabilization ofthe anastomosis site is paramount if the surgeon is to effectivelyperform the suturing/anastomosis task. Also, the working spacesurrounding the anastomosis site is quite limited, and visibility of thesite is also extremely important to the surgeon, who will perform thesuturing tasks visually. Thus, instruments involved in the procedureshould be minimal in size and place a premium on being located in areasleast likely to obstruct the surgeon's view while performing theprocedure, while also maintaining sufficient access space for theinstruments needed in conducting the suturing and related procedures.The instruments should also be easy to operate and effective atstabilizing a desired area of tissue on the heart. Since this desiredarea may vary, the instruments should be extremely maneuverable so as tobe versatile for use in many, if not all desired target locations on theheart.

A tissue stabilizer employed for this purpose may have one or morestabilizer feet, preferably at least a pair of feet to be positioned onopposite sides of the coronary artery to be operated upon. The contactsurfaces of the stabilizer malt be adjustable as to the orientation withrespect to the remainder of the stabilizer to adjust to a proper contactof the tissue surface. Various types of stabilizer feet may be employed,including those with one or more mechanical stabilization surfaces, aswell as those having one or more contact members that grasp the surfaceof the heart by suction.

FIG. 1B shows an example of a mechanical stabilizer 140 that may beemployed in the present method. Stabilizer 140 is shown mounted on rail418 of blade 416 of the retractor 4 (note only a portion of theretractor, i.e., blades 414 and 416 are shown in FIG. 1B). Thestabilizer 140 is first mounted to the retractor assembly 4 (e.g., at alocation on one of the rails 418 that provides advantageous positioningof the stabilizer 140). In the example shown in FIG. 1B, the stabilizer140 is a multi-jointed device which provides the flexibility needed toreach less direct surfaces of the heart from the incision opening,Additionally, stabilizer 140 is extremely low profile to maximize theamount of free space available in the opening for use by the surgeon. Inthe example shown in FIG. 1B, stabilizer 140 includes a heart contactmember 120 adapted to contact the heart adjacent the site desired to bestabilized. The contact member 120 may include a pair of feet or contactmembers 122 as shown in FIG. 1B, which may be substantially planar, orslightly curved to conform to the shape of the heart, or one or more mayhave a non-conforming curve to establish a contact between only aportion of the contact member 120 and the beating heart. The shape ofthe feet 122 and the contact member 120 may be varied depending on theclinical assessment by the surgeon, the design of the remainder of thestabilizer 140, and/or the design of other instruments to be used tocomplete the anastomosis.

As noted earlier, the stabilizer may employ a contact member or membersthat use vacuum or negative pressure to effect stabilization of thetissue. FIG. 1C shows an example of a contact member 160 that isconfigured to facilitate the use of negative pressure to engage thesurface of the heart. Contact members 162 may each be provided with athin, compliant seal 164 which is preferably molded into the contactmember. Seal 164 is very compliant and flexible, with a Shore hardnessof about 50, for example, and tapers similar to a “knife edge”, so thatit conforms easily to the topology of the tissue that it contacts when avacuum is drawn through the contact member 162, thereby providing aneffective seal between the heart contact member 160 and the tissue.Optionally, the distance that the seal extends from the contact member602 may scary such that it extends by a relatively greater distance nearthe tip or distal end of the contact member 162 to provide a variableseal (as shown in phantom by reference numeral 164′ in FIG. 1C). Thevariable seal configuration may help to ensure that a seal is maintainedat the distal end of the contact member 162 and that a vacuum pathway isalso maintained, as the cross sectional area and thus volume of thedistal end is reduced.

Contact members 162 may be connected to manifold base 166. Additionally,the contact members 162 preferably retain the ability to rotate withrespect to the manifold 166. Connecting element 168 is fixed to themanifold 166 opposite contact members 162, and which is adapted toconnect the contact member 160 to the distal end of stabilizer arm 130.Although various types of connections may be used to perform this task,in the examples shown in FIGS. 1B and 1C, connecting element 168includes a ball portion 180 that is configured and dimensioned to bereceived in a socket member contained in distal connector 132 at thedistal end of arm 130, and a stem 178 which interconnects ball portion180 with contact member 160. A rotatable fitting 172 is rotatablyconnected to manifold 166 and is adapted to fluidly connect the contactmembers 162 (via manifold 166) with a vacuum line (not shown) that isconnected to a source of vacuum. In this way, the contact members 162and manifold 166 can be rotated while maintaining a constant position ofthe rotatable joint 172 and the vacuum line connected to it. An inletlube 174 having an inlet opening 176 is provided to fluidly connect thevacuum line with a hollow space or chamber defined within manifold base166 and rotatable fitting 172. Further descriptions of the stabilizercontact members described above can be obtained in U.S. application Ser.No. 09/769,964 filed on Jan. 24, 2001, and titled “Surgical Instrumentsfor Stabilizing a Localized Portion of a Beating Heart”, which is herebyincorporated by reference thereto, in its entirety.

The present invention is not limited to the use of stabilizers asdescribed above. Any stabilizer that is capable of cooperating with anorgan manipulation apparatus according to the present invention toeffectively stabilize a portion of the heart in an area of the surgicaltarget, without substantially adversely effecting the continued beatingand cardiac output of the heart may be used. Other non-limiting examplesand descriptions of stabilizers that may be employed in the presentmethods include those described in U.S. Pat. Nos. 5,906,607; 5,894,893;6,036,641; 6,290,644; 6,050,266; 6,213,941; 6,315,717; 6,406,424 and6,511,416; each of which are hereby incorporated by reference thereto,in their entireties.

Referring again to FIG. 1B, stabilizer 140 includes a highlymaneuverable arm 130 which connects the contact member 120 through abase member 142 to a tightening mechanism 150 at the proximal end of thedevice. The maneuverable arm 130 includes multiple articulating jointswhich enable the contact member 120 to be positioned and set at a widevariety of positions, virtually enabling the contact member 120 to beused for any target site in performing anastomoses according to thepresent invention. The multiplicity of articulating joints allowversatile positioning, and a cable which runs through each of the jointsand interconnects them with the tightening mechanism 150, may betensioned to freeze the selected orientation of the device in a rigidconfiguration. In this way, the contact member 120 can be maintained atthe desired orientation to provide stabilization to that portion of theheart tissue with which it makes contact, as well as the immediatelysurrounding area A more detailed discussion of the articulatingelements, cable, base member and tightening mechanism can be found inU.S. application Ser. No. 09/769,964.

Thus, after mounting the stabilizer 140 to the retractor assembly 4, themaneuverable arm 130 and contact member 120 are manipulated so as toposition the contact member against the surface of the heart in thedesired area so as to stabilize that portion of the heart to facilitateperformance of the anastomosis. When a mechanical contact member isused, a pressure is applied against the heart tissue via contact member120 which is sufficient to substantially immobilize that area of theheart surface, but not so great as to effect the beating of theremainder of the heart. When a contact member that employs negativepressure is used, a negative pressure is generated between the contactmember and the tissue contacted so that the contact member grasps thetissue and stabilizes it. With use of either mechanical contact membersor contact members employing negative pressure, When at least a pair ofcontact members are employed, a further step of spreading the contactmembers away from one another may be employed to increase the surfacetension of the tissue therebetween, which serves to further stabilizethe tissue.

Once the contact member or members have been satisfactorily positionedto effectively stabilize an area of tissue, the stabilizer is fixed inposition to maintain the stabilization during the procedure to beperformed. In the example shown in FIG. 1B, the fixing is accomplishedby turning the knob of the tightening mechanism 150 which tensions thecable running through the articulating joints of arm 130 whicheffectively compresses the joints together, thereby locking them intheir relative positions, and at the same time, clamps base member 142more tightly to rail 418. Of course, various other arms, base membersand connectors/joints may be used in a stabilizer to effectivelyposition a contact member and then fix it in that position relative to astationary object. For example, in place of the articulating arm 130, arigid arm such as a straight shaft, tubular member or curved arm may bemovably mounted to a base member such that it can be repositioned forproper placement of a contact member.

FIG. 1D shows an example of a stabilizer 140 that is mounted to rail 418via base member 142. In this example, stabilizer 140 employs a curved,substantially rigid support arm 130, connected to contact member 120 toallow movement of three degrees of freedom of the contact member withrespect to arm 130 in an unlocked condition. The base member 142, inthis case, includes features to secure base member 142 at a desiredposition on an appropriately configured mating rail or other suitablestructure and includes an arm locking mechanism for controlling andsecuring an arm of an instrument in a desired position and orientation.One important aspect of this base member 142 is to provide the necessarydegrees of freedom to allow the arm 130, and thus the contact member 120as well, to be easily maneuvered to whatever position may be required bya particular procedure. As discussed above, an additional aspect withrespect to stabilizing the beating heart is to eliminate or minimize theflex or motion attributable to the various components and connections ofbase member 142. Base member 142 is uniquely suited for use instabilizing the beating heart because it allows sufficient degrees offreedom to easily manipulate the position of an instrument securedthereto, allows the degrees of freedom to be frozen or locked in placeand once locked in place, does not significantly flex or allow movementat any of the mechanical joints or connections.

Base member 142 provides a number of different controllable joints that,when in a released condition, allow motion in one or more predetermineddirections or about one or more degrees of freedom. Although base member142 may be used to secure any arm member configuration from straight orcurved substantially rigid arms to multi-link or segmented ball andsocket type arms which are relatively flexible until themselves lockedin some manner at each joint along the arm length, it is mostadvantageously constructed to provide the joints or connections requiredto position an instrument having a straight or curved rigid arm 130.

Base member 142 may have three releasable joints or connections forcontrolling the location and position of the instrument arm 130. Thebase member 142 may be positioned at a desired location along anappropriate rail and secured by rail grips 144 and 146. The position andorientation of the instrument is then determined by ball joint (or balland socket joint) 143 between mount base 125 and mount body 126, arotational joint 147 between mount body 126 and arm hub assembly 127,and an arm clamping mechanism within arm hub assembly 127 which mayallow translation, rotation, or both of arm 130 relative to arm hubassembly 127.

Ball joint 143 is preferably of the ball and socket type having 3rotational degrees of freedom. Rotational joint 147 allows rotation ofarm hub assembly 127 about axis 121 as indicated by arrow 113. The armclamping mechanism allows translation of instrument arm 130 as indicatedby arrows 111 as well as rotation about the arm itself as indicated byarrow 117. A further ball-joint type connection 139 may, be employedbetween arm 130 and the contact member 120 to allow movement of contactmember 120 with respect to arm 130 about three degrees of freedom. Alocking mechanism controlled by rotatable knob 137 controls theconnection 139 between an unlocked state in which the contact member isfree to move with respect to arm 130, and a locked state in which thecontact member 120 is fixed with respect to arm 120.

Base member 140, having the particular joints and connections identifiedabove, allows all the required areas of the heart to be conveniently andintuitively accessed by a stabilizer connected to one end of asubstantially rigid arm. Certainly, base member 140 could be providedwith more or less degrees of freedom for maneuvering a particularinstrument. For example, to add additional degrees of freedom rotationaljoint 147 could be replaced with a ball joint and to eliminate degreesof freedom arm 130 could be keyed within arm hub assembly 127 or balljoint 143 could be replaced with a rotation only joint, for example.However, it should be noted that excessive degrees of freedom may tendto make instrument adjustment increasingly difficult and cumbersome tocontrol while too few degrees of freedom may not allow the instrument tobe easily placed in the desired position or orientation.

In the example shown in FIGS. 1D-1E, the various joints and connectionsare locked into a desired position by way of a series of knobs. Thedegrees of freedom provided by ball joint 143 are locked by activationof top mount knob 115. Both rotational joint 147 and the arm clampingmechanism of arm hub assembly 127 are locked in place by the activationof side mount knob 116. Base 125 is locked in position on the rail byactivation of mount lever 114. Ball joint 139 may be locked in positionby activation of knob 137, as noted above. This particular sequence ofknobs used to lock down the degrees of freedom associated with basemember 140 tends to allow the user greater precision in positioning theinstrument because degrees of freedom unnecessary to a particulardesired maneuver of the instrument can be locked down. Most commonly,mount body 126 is placed at a desired angle or orientation and thenfixed in place by locking ball joint 143, leaving final adjustment totake place using rotational joint 147 and the arm movement allowed bythe arm clamping mechanism of arm hub assembly 127. Again this is justanother example of a stabilizer and mount that can be used inconjunction with an organ manipulator according to the present inventionto carry out the methods described herein. A more detailed descriptionof tile stabilizer and base member mount shoots in FIGS. 1D-1E can befound in U.S. Pat. No. 6,331,158.

Upon completion of the surgical procedure, such as an anastomosis, atthe surgical site having been stabilized by stabilizer 140, the contactmember 120 is removed from contact with the heart tissue, such as byreleasing tension from tensioning knob 150 and manipulating the flexiblearm (now in the unlocked, flexible state) and contact member away fromthe tissue, or by releasing whatever other mechanisms are employed forfixing the stabilizer in the stabilizing position, so as to enable theremoval of the contact member from contact with the tissue. In the caseof use of a suction stabilizer, the vacuum or negative pressure will, ofcourse, be discontinued prior to removing the contact member from thetissue. After removal of the contact member from contact with thetissue, stabilizer 140 is then completely removed from the site, byremoving base member from its location of fixation (e.g., rail 418) andthen physically removing the entire instrument.

Repositioning of the heart 2 is performed by unlocking the organmanipulation apparatus 10 from its gross positioning configuration,thereby allowing movement of arm 40 with respect to retractor 4. In theexample shown in FIG. 1A, this is accomplished by releasing tension froma cable running through the multiple components of arm 40, by turningtensioning knob 50 in a counterclockwise direction. Suction ismaintained between suction member 20 and heart tissue 2 at this time.The now flexible arm is manipulated so as to slowly lower the heart 2back into is normal position. Upon returning the heart to its normalposition, vacuum is discontinued and suction member 20 is removed fromits contact with the heart. Base member 42 can then be removed from itslocation of fixation and the entire organ manipulation apparatus 10 canbe physically removed from the site to allow more working space forcompleting the surgical procedure.

Suction Member

Referring now to FIGS. 2A-2E, sectional views of various stages in themanufacture of suction member 20 are shown. FIG. 2A is a sectional viewof the completed suction member 20, which, in this case is an all foamcontact member 22 having a plastic mounting stem 24 mounted thereto forfluidly connecting the suction member 20 with a vacuum line 7. Arotational connector 38 may be provided to interconnect mounting stem 24with vacuum line 7 to allow relative rotation between these twocomponents, so that when suction member rotates with the heart, suctionline can remain in the same position, thereby preventing tangling oradditional forces on the heart that may be detrimental to the normalbeating of the heart. Suction member 20 in FIG. 21 is adapted for use oneither the apex of the heart of on the ventricles. The foam contactmember 22 is more compliant than a silicone cup and provides greatercushioning of he heart tissue, thereby reducing the risk of hematoma orother trauma to the heart tissue caused by grasping it with a suctiondevice.

Initially, a foam disk (e.g., polyurethane or other biocompatible foam)is molded to have a skin 22 a on one side thereof, as shown in FIG. 2B.The skin 22 a is substantially air impermeable, which is necessary inorder to generate a pressure differential between the inside and outsideof the contact member. The remainder of the body of the foam 22 f, ofcourse, is porous and allows air flow; therethrough. A central opening22 o is formed in the skin, such as by cutting or drilling to remove asmall disk 22 d of the skin, as shown in FIG. 2C. Next, the foam disk isflexed or bent as indicated in FIG. 2D, thereby beginning to form thecup-shape that the contact member 22 will eventually assume.

In order to form the necessary airtight seal that is required forforming a vacuum against the tissue surface and thereby grasping it, thecontact surface c of the contact member must also be substantially airimpermeable. Otherwise, air Would be able to flow or leak through theperiphery of the disk is the porous layer 22 f contacted the tissue anda vacuum were attempted to be drawn. To make the contact surfaceimpermeable, the edges of the disk are folded under, as shown in FIG. 2Eand bonded to the underside of the disk, using either a biologicallyacceptable glue or heat bonding, for example. Finally, stem or shaft 24is centered over the central opening 22 o and bonded to the skin 22 afor complete the configuration shown in FIG. 2A. Upon application ofvacuum through the annulus 24 a of shaft 24 air is filtered through themultiplicity of pores in the foam member 22 and then drawn throughopening 22 o and finally into the annulus 24 a. Advantageously, the foam22 f diffuses the air flow and prevents tissue from being sucked up intoopening 22 o or annulus 24 a thereby greatly contributing to preventionof suction blockage by the tissue and reduction of trauma to the tissue.

FIG. 3 is a sectional view of another example of a suction member 20according to the present invention. This is similar to that shown inFIG. 2A in that an open-celled foam 22 f having an outer skin 22 a isprovided. However, this suction member further includes an outer shellmember 25 made of a material that is stiffer or more rigid that foam 22,a material such as a soft silicone, for example. The silicone layer mayextend flush with t4 h skin 22 a at the opening of the suction member,or, alternatively, may not extend that far (as shown by the phantomlines 25 p) so that the interface between the suction member 20 andtissue is more flexible and forms a better seal that is more resistantto leak-age. The shell member 25 makes it less likely that a vacuumdrawn within member 20 can collapse the space in which the vacuum iscreated, thereby enabling a relative large volume of open-celled foam todiffuse the air flow and cushion the tissue that is drawn into thevacuum space.

FIG. 4 shows another variation of a suction member 20 in which a shellmember 25, similar to that in FIG. 3 is employed. However, rather thanproviding an open-celled foam layer interiorly to shell member 25, thisvariation includes a tissue restraint member 26 (such as webbing whichmay be formed of nylon strands or the like, for example) which functionsto restrain or limit tissue from being drawn any further into thesuction member 20. That is, when suction is applied, tissue can besucked into the suction member until it contacts the tissue restraintmember 26, but, since tissue restraint member 26 is substantiallyinextensible, it substantially prevents migration of tissue beyond theboundary defined by tissue restraint member 26. An additional benefit isthat the tissue restraint member 26 prevents the tissue from beingoverstretched or overstressed by the applied vacuum, thereby preventingbruising, tearing and other trauma to the tissue. A vacuum bafflechamber 27 is defined between tissue restraint member 26 and the innersurface of shell member 25 in which tissue is prevented from entering bytissue restraint member 26 upon application of vacuum through shaft ortube 24. Thus, vacuum baffle chamber ensures that a suction pathway ismaintained between the tissue and the annulus of the substantially rigidshaft 24. The shell member is sufficiently rigid to prevent collapsethereof under vacuum. thereby ensuring that the vacuum baffle chamber 27is maintained. The inner lip 25 a of the shell member is highly roundedto form an atraumatic surface for grasping the tissue. The tissuerestraint member 26 is attached above the highly rounded lip 25 a by anyof the aforementioned attachment techniques.

FIG. 5 is a sectional view of another example of a suction member 20having a tissue restraint member 26 therein. In this example, a hardplastic cup 25, made of a hard/rigid and biocompatible plastic assuresthat no deformation of the shell 25 occurs under application of vacuum.Tissue restraint member 26 functions in the same manner as thatdescribed with regard to the example in FIG. 4 and is therefore notrepeated here. In order to form an adequate vacuum seal with the tissue,the opening of this variation is provided with a foam seal 25 a aroundthe perimeter thereof Foam seal does deform upon contact with the tissueand formation of a vacuum in the vacuum baffle chamber 27, therebyforming a better, more air impermeable interface with the tissue that itis deformed against.

FIG. 6 is a sectional view of another variation of a suction member 20according to the present invention. In this variation, the contactmember is formed of a soft elastomeric cup such as a silicone cup 25.Cup 25 that includes grooves 25 g in the inner wall thereof, each ofwhich fluidly connect with annulus 24 a of shaft member 24. In this way,upon contacting the suction member 20 with tissue and applying vacuumthrough annulus 24, even if tissue is sucked up into the suction memberso far as to contact the inner walls of the cup 25, grooves 25 g ensurethat an open vacuum flow path is maintained and therefore the suctionmember does not lose its grasp of the organ it is applied to, since thevacuum is maintained. Even if the tissue presses against the entireinner surface of the cup 25, the channels or grooves 25 g maintain openpathways for the vacuum. Thus, a very low profile cup can be made withlittle risk of clogging or blocking of vacuum.

FIG. 7A is a sectional view of a suction member 20 that includes animpermeable layer 28 with a pattern of holes 28 a formed therein toallow air flow therethrough upon application of vacuum through shaft ortube 24. FIG. 7B is a top view of the impermeable layer 28 which moreclearly shows the hole pattern formed by holes 28 a. The hole patternshown is random, but is not necessarily so. All that is required is apattern that is disperse over the surface of the impermeable layer 28,as this serves to disperse the flow pathways of the applied vacuum whichgreatly reduces the chance of completely blocking the vacuum flow pathswith tissue. This suction member is configured to be used preferably atthe apex of the heart, although it may be applicable to other locationson the heart and is applicable to use on other organs.

An open cell foam layer 22 f lines the majority of the inner surface oflayer 28 and at least covers each hole 28 a. The open cell foam layer 22f further disperses the vacuum flow to provide an even distribution ofthe vacuum over the surface of the tissue that is contacted by it. Opencell foam layer 22 f also enhances the structural integrity of thesuction member 20 and helps prevent impermeable layer 28 from collapsingor buckling under the applied vacuum load. A thin, flexible skirtextends from the periphery of the impermeable layer 28 and beyond theperiphery of open cell foam layer 22 f, to enhance the sealing functionof the suction member at the location of contact with the tissue. Skirt28 s may be made of a soft, flexible silicone, for example, and may bean extension of impermeable layer 28, or may be made of a separatesofter durometer material than the impermeable layer 28. Impermeablelayer 28 is further supported to prevent collapse by outer foam layer 29f which covers all or the majority of the outer surface of layer 28 andat least covers each hole 28 a. The open cell foam layer 29 f may bemade of the same material as layer 22 f with the same porosity.Alternatively, a different open cell foam may be used, and whether thesame material as used or not, the porosity of layer 29 f may be chosento be smaller or larger than that of layer 22 f. Foam layer 29 f fluidlyconnects holes 28 a with the tube or shaft 24 which is to be connectedto a vacuum line for supplying negative pressure to the suction member20. An outer impermeable layer 29 overlays outer foam layer 29 f andseals with impermeable latter 28 peripherally all the way around thelayer 28 at a location 29 a beneath all holes 28 a, as well as with thesubstantially rigid shaft or tube 24, so as to prevent any vacuumleakage between holes 28 a and the annulus of tube 24. Outer impermeablelayer may be a silicone layer or made from some other flexible,substantially air impermeable elastomer or material that isbiocompatible. Outer impermeable layer 29, as opposed to layer 28,contains no holes since it performs a containment function, rather thata dispersal function.

FIG. 8A is a sectional view of a suction member 20 that includes amalleable or flexible impermeable layer 28 to establish a vacuum spaceon the inside thereof when a negative pressure is applied through shaft,tube or stem 24 which is fluidly connected with the space defined by theinner surface of impermeable layer 28. This suction member is configuredto be used preferably at the apex of the heart, although it may beapplicable to other locations on the heart and is applicable to use onother organs. An open cell foam layer 22 f lines the majority of theinner surface of layer 28 and provides support and structural integrityto layer 28 to prevent it from buckling or collapsing under theapplication of vacuum. The open cell foam layer 22 f further dispersesthe vacuum flow to provide an even distribution of the vacuum over thesurface of the tissue that is contacted by it. A thin, flexible skirt 28s extends from the periphery of the impermeable layer 28 and beyond theperiphery of open cell foam layer 22 f, to enhance the sealing functionof the suction member at the location of contact with the tissue. Skirt28 s may be made of a soft, flexible silicone, for example, and may bean extension of impermeable layer 28, or may be made of a separatesofter durometer material than the impermeable layer 28. Skirt 28 s maytaper in thickness, as shown in FIG. 8A, so that it is thinnest at theend away from where it connects with layer 28. This further enhances theflexibility and sealing function of the skirt. As demonstrated in FIG.8B, skirt 28 s can be retracted or “rolled up” upon initially placingsuction member 20 in contact with tissue to be grasped. Then, uponrelease of the skirt 28 s (which may be retracted manually, forexample), the skirt 28 s “rolls down” on the tissue to closely conformto the contours of the tissue thereby forming a superior seal. Thus,upon placement of suction member 20 and seal as described, a negativepressure is next applied through tube 24 which draws air existingbetween the tissue and suction member 20 through dispersed flow pathsdefined by the porosity of layer 22 f and into tube 24. This flow causesa suction force that increases the strength of the air proof sealbetween skirt 28 s and the tissue. The dispersed flow paths through foam22 f tend to distribute the suction force fairly evenly over the surfacearea of the tissues which is bounded by skirt 28 s, thereby reducing thechances of focusing a small portion of tissue with the vacuum flow andpulling it into suction member 20 by an excessive amount which couldblock the vacuum flow and cause release of the seal and/or damage tietissue.

FIG. 9A is a sectional view of another variation of a suction member 20that includes an impermeable layer 28. In this impermeable layer 28, aplurality of openings 28 b are formed, each at a location where a vacuumtube 24 b,24 c,24 d, etc. is joined to fluidly connect with the interiorof the suction member. Each of the plurality of vacuum tubes joins intothe substantially rigid shaft 24 where the, are fluidly connected with asource of vacuum. This suction member is configured to be usedpreferably at the apex of the heart, although it may be applicable toother locations on the heart and is applicable to use on other organs.An open cell foam layer 22 f lines the majority of the inner surface oflayer 28 and covers at least each opening 28 b. The open cell foam layer22 f further disperses the vacuum flow to provide an even distributionof the vacuum over the surface of the tissue that is contacted by it.Open cell foam layer 22 f also enhances the structural integrity of thesuction member 20 and helps prevent impermeable layer 28 from collapsingor buckling under the applied vacuum load. A thin, flexible skirt 28 sextends from the periphery of the impermeable layer 28 and beyond theperiphery of open cell foam layer 22 f, to enhance the sealing functionof the suction member at the location of contact with the tissue.

FIG. 9B is atop view of the impermeable layer 28 of the suction member20 shown in FIG. 9A. As shown, impermeable layer 28 includes a regularlyspaced pattern of openings 28B (six in this case, although greater orfewer openings could be employed) surrounding a central opening 28B andarranged in a ring for even distribution of vacuum Although the centralopening 28B is shown larger than the other openings 28B, it need not beso, as all openings could be formed to be the same size and stillachieve the desired distribution of vacuum over the inner surface of thesuction member. Thus, upon placement of suction member 20 and skirt 28 sas described, a negative pressure is next applied through tube 24 whichdraws air existing between the tissue and suction member 20 throughdispersed flow paths defined each of the openings 28 b and associatedvacuum tubes. Layer 22 f further distributes and disperses the flowpathways through the numerous pores therein, so that the applied vacuumis fairly evenly distributed over the surface area of the tissue whichis bounded by skirt 28 s, thereby reducing the chances of focusing asmall portion of tissue with the vacuum flow and pulling it into suctionmember 20 by an excessive amount which could block the vacuum flow andcause release of the seal and/or damage the tissue. Still further, inthe off chance that a vacuum opening 28 b does become blocked by tissue,other openings 28 b exist to maintain the applied vacuum force to thetissue and therefore the suction member retains its grasp on the tissueand maintains the organ in its desired retracted position.

FIG. 10A is a sectional view of another variation of a suction member 20that includes an impermeable layer 28, with a plurality of openings 28b, like in FIG. 9A, each at a location where a vacuum tube 24 b,24 c,24d, etc. is joined to fluidly connect with the interior of the suctionmember. Each of the plurality of vacuum tubes may be joined into asubstantially rigid shaft 24, as described above with regard to FIG. 9A,where they are fluidly connected with a source of vacuum. Alternatively,any one or more of the vacuum tubes may be formed to be substantiallyrigid so as to connect the suction member 20 to a suspension thereby.Also, each vacuum line may be individually or independently connected toa source of vacuum. Still further, pairs or other groups of vacuum linesmay be joined to a connecting vacuum line for connection to a source ofvacuum. In this way, it is possible to connect suction member 20 to morethan one vacuum source to provide redundancy, if desired. Foam donuts 22d surround each of the openings 28 b on the inside of layer 28, as seenbest in the bottom view of FIG. 10B. Donuts 22 d ma) be made of an opencell foam of the type described above with regard to open cell foamlaver 22 f. Donuts 22 d provide cushioning for the tissue that isgrasped by the suction member 20, while at the same time functioning asspacers, to maintain openings 28 b at a distance from contacting thetissue and being plugged. This ensures better distribution of vacuumthrough the porous donuts 22 d. Also, there is less attenuation of thevacuum through the vacuum openings than in previously describedembodiments, since no foam covers the openings 22 d, which can applyvacuum directly through the donut holes. Although a central opening isnot shown in FIG. 10A, a central opening 28 d (shown in phantomsurrounded by phantom donut 22 d in FIG. 10B) may optionally be used inaddition to the ring of openings 28 d. A further characteristic of thisconfiguration is that the impermeable layer retains a

FIG. 11 is a sectional view of another example of a suction member 20according to the present invention. This is similar to that shown inFIG. 3 in that an outer shell 25 is provided to contain open-celled foam22 f which may or may not have an outer skin. A very thin, soft sleeve25 s is further provided and is very flexible and capable of telescopingas shown in FIG. 11. However, sleeve 25 s is molded in a straightextended configuration so that it maintains a memory for the straightconfiguration. In practice, suction member is applied to tissue suchthat sleeve 25 s assumes the telescoped position shown in FIG. 11 and avacuum is applied, thereby establishing a seal between the tissue andsleeve 25 s. In the case where the tissue is a portion of a beatingheart, sleeve 25 s, being biased in the extended “memory” position, isbiased to “chase” the heart tissue as it retracts during a contractionphase of the heartbeat, and this provides added assurance of maintainingthe seal between sleeve 25 s and the heart tissue. Thus, sleeve 25 sadds compliance to suction member 20 to ensure better maintenance of aseal between the sleeve and moving tissue.

FIG. 12A is a sectional view of another example of a suction member 20according to the present invention. This example includes a semi-softouter shell 25 which may be made of a porous foam having a skin on bothsides, or may be a dual layer of silicone or other pliable materialfilled with porous foam. Internally of the shell 25, a porous foamcomponent 22 f is provided to distribute the applied vacuum as well asto cushion the material to be grasped and to enhance the structuralintegrity of the suction member 20. A capacitance chamber 25 c may beprovided in shell 25 between an opening 25 a on the inner surface ofshell 25 and tubular member 24, and fluidly connected between the same,to provide additional capacitance for the applied vacuum. The sealingfunction of this example is enhanced by providing a verb, soft. pleatedor accordioned skirt 25 p that has the ability to conform well to thetissue that is seals with upon initial placement, and which further hasthe ability to chase or follow tissue (such as beating heart tissue) asit moves away from suction member 20. Thus, pleated or accordioned skirt25 p functions as a suspension so as to limit adverse effects of thesuction member on the natural motions of the heart as it beats.

FIG. 12B is a sectional view of another example of a suction member 20according to the present invention, in which a silicone or otherequivalent elastomeric material is used to form the main body or cup 25of the suction member 20, and is constructed with a pleated oraccordioned geometry 25 p to provide a suspension function and also toprovide additional spacing within the body 25 and extensibility tobetter conform to different geometries along the surface of a heart orother organ or tissue. This configuration enhances the ability to engageon all areas of the heart, and particularly the apex. The deep pocketand suspension like features of the body 25 create a geometry that willreadily engage with a curved or flat tissue surface. The suspensionfurther enhances the compliance of the suction member for following thecontraction and relaxation of the beating heart. The deep pocket createdby the extensibility of this design creates a large volume in which toengage tissue, thereby creating a strong overall hold while at the sametime distributing the holding force over a large area so as not todamage the tissue.

A foam diffuser or seal 25 f is mounted to the inner flanges at thebottom of body 25 to facilitate the vacuum seal at the location ofcontact with the tissue to be grasped. The inner flanges further createvacuum pockets that enhance a strong seal upon engagement of the member20 with tissue. The foam used to form seal 25 f is preferably Volara®Zeo (http://www.reillyfoam.com/volara.htm). The seal is die cut from asheet of the foam material which greatly reduces manufacturing costs.

The body member 25 and corresponding diffuser 25 f may be circular inshape as shown in the bottom view of FIG. 12C, they may also be formedin different shapes, such as oval, elliptical or saddle shaped, forexample, for conforming to various topographies of tissue surfaces.

FIG. 12D is a sectional view of another example of a suction member 20in which body or cup 25 is made of silicone or other equivalentelastomeric material and is constructed with a pleated or accordionedgeometry 25 p to provide a suspension function and also to provideadditional spacing within the body 25 and extensibility to betterconform to different geometries along the surface of a heart or otherorgan or tissue. This body member 25 and corresponding diffuser 25 f areoval-shaped from a bottom view, as shown in FIG. 12E. Additionally, thebottom surface of body 25 is curved upwardly 25 z causing conformingdiffuser 25 f to also have the same upward curvature 25 z along the longportions of the oval shape, so as to form a “saddle shape” whichconforms well over a curved or rounded tissue surface conformation, suchas an apex of a heart for example, thereby enhancing the engagement ofthe suction member 20 with the tissue.

FIGS. 13A-13C, show another suction member 20 that is deformable to forma seal and enhance organ capture. Suction member 20 preferably compriseselastomeric material 28 (e.g., silicone) having a flat, seal-supportingflange 28 f at its distal end. Optionally, a foam seal 25 f is attached(preferably by suitable adhesive) to flange 28 f. Seal 25 f preferablycomprises a die-cut, flat, annular piece of foam; flange 28 f is alsopreferably flat and annular. Upon the application of vacuum, the flangemember (or flange and foam member) flex into a state in which theyconform to the organ's contours as shown in FIG. 13B. In thisconfiguration, seal 25 f and/or flange 28 f has flexed into a generallyfrusto-conical configuration. The flexible interface thus provides anexcellent seal as it conforms to the contour of tissue adjacent thereto.Further, (though to a lesser extent), it provides the suction member 20to chase or follow tissue (such as beating heart tissue) as it movesaway from the suction member.

FIG. 13C is a cross-sectional view of a preferred implementation ofsuction member 20 of FIG. 13A when it includes a seal 25 f. In thisimplementation, foam seal 25 f is annular, and flange 28 f has an innerperiphery 29 p whose radius varies, e.g., sinusoidally as shown, so asto define cut-outs which expose portions of seal 25 f directly to thesource of suction. With flange 28 f so-shaped, the flange-sealcombination may enjoy increased flexibility since the cutouts removeconstraints otherwise present on the foam if it were bonded to a fullannular flange section.

It is noted that the above-described suction member variations whichhave been shown and described as being used with a substantially rigidshaft or tube for interconnection with a vacuum tube and vacuum sourceand a suspension, may be used with other organ manipulation devicesdescribed herein. For example, a flexible or elastomeric tubing could beprovided for interconnecting any of the described suction members orequivalents with an apparatus of the types described in FIGS. 20 and 21below. As another example, each suction member could be provided with anopening in a tube or shaft so as to cooperate with the suspension shownin FIG. 24, and so forth. That is, the suction members can be adapted tocooperate with any of the organ manipulation apparatuses/devicesdescribed herein.

Suspension

Regardless of the type of suction member that is employed in an organmanipulation device 10 according to the present invention, a suspension30 is provided which interconnects the suction member with a supportstructure that is relatively immobile when fixed in a retractionposition. Suspension 30 permits limited motion of suction member 20 evenafter the support structure has been rigidly fixed. This is an importantaspect of the organ manipulator, since it permits substantially normalbeating of the heart, even as the organ manipulator maintains the heartin a retracted position.

FIG. 14A shows one example of a suspension 30 which allows both rotationand a limited amount of translation of suction member 20 (and any organthat it may be attached to) with respect to a support structure, such asarm 40, even after arm 40 has been rigidly fixed to a stationary membersuch as retractor 4. Suspension 30 includes a clevis or fork portion 32which may be molded from a structurally rigid polymer such aspolycarbonate, for example, or machined from stainless steel, etc. Fork32 includes protrusions 32 p, knurling or other friction enhancingfeatures that allow the suspension to be more positively grasped andmanipulated during both placement of the organ manipulator, andparticularly during gross retraction of an organ. A bore 32 b isprovided in each arm of the fork 32 to receive a roller therein. Aconnector, such as ball and shaft 32 c extends from clevis 32 and isadapted to rotatably mount suspension 30 with respect to a support arm40. The shaft portion of connector 32 c may be press fit into a holeprovided in the proximal end of fork 32, for example. Preferably, clevis30 is rotatable about the longitudinal axis of the shaft of connector 32c with respect to the support arm 40 when the support arm has not yetbeen fixed into a rigid configuration. This allows an additional degreeof freedom to rotate the clevis (and suction member 20) for properorientation of suction member in approximating the tissue to be grasped.After applying suction, grasping the tissue and grossly positioning theorgan, support arm 40 is fixed and this also fixes connector 32 c withrespect to the support arm so that fork 32 is no longer rotatable aboutthe longitudinal axis of the shaft of connector 32 c with respect tosupport arm 40. Alternatively, the ball of connector 32 c and distal endof support arm 40 can be configured such that, even after substantiallyfixing the support arm, the suspension continues to be able to rotateabout the longitudinal axis of the stem of connector 32 c with regard tosupport arm 40.

Roller 34 may also be molded from polycarbonate and is dimensioned to bereceived in bores 32 b to freely rotate within bores 32 b. In the casewhere fork 32 is molded from polycarbonate or other substantially rigidpolymer, the arms of the fork can be slightly flexed to allow insertionof end pins of the roller 34 into the bores 32 b. In the case of a metalfork, pins may need to be press fit into roller 34 from outside of bores32 b after positioning the main body of roller 34 in place, therebyaligning it with bores 32 b. Roller 34 further includes a central bore34 b dimensioned to receive mounting stem 24 and to allow free rotationand translation of mounting stem 24 with respect to roller 34.Additionally, the rotation of roller 34 about its longitudinal axisallows “swinging” of the suction member about an angular range that isgreater than previously described ball joint connectors.

After passing mounting stem 24 through bore 34 b, a biasing member 36,such as a coil spring for example, is positioned between roller 34 andconnector 38. A counter bore 34 c may be provided in roller 34 that isslightly larger than bore 34 b and dimensioned to receive an end ofbiasing member 36, so that it seats in counter bore 34 c. Connector 38may be press fit, glued, or otherwise fixed over mounting stem 24 toprovide an airtight connection therewith. Connector 38 includes a stemportion 38 c which is preferably freely rotatable with respect to theportion of connector 38 that is fixed to mounting stem 24, so that whensuction member 20 rotates, the suction tube that connects stem portion38 c to a source of negative pressure is allowed to remain insubstantially the same position, thereby preventing kinking or tanglingof the suction tube or line. The outside diameter of connector 38 whereit meets biasing member 36 is larger that the outside diameter ofbiasing member 36. In this way, a limited amount or translation ofmounting stem 24 (and thus, also suction member 20 and any organattached thereto) is allowed, with biasing member 36 tending to bias theshaft in an upward direction and opposing the weight of suction member20 and an organ attached thereto. The suction member 20 is allowed tofreely rotate about 360 degrees with respect to roller 34.

The suction member 20 shown in FIG. 14A is a silicone cup that employs afoam seal 25 f around the perimeter thereof to facilitate the vacuumseal at the location of contact with the tissue to be grasped. The foamused to form seal 25 f is preferably Volara® Zeo. The seal is die cutfrom a sheet of the foam material which greatly reduces manufacturingcosts. An alternative seal 25 c is shown in the partial sectional viewof FIG. 14B. Seal 25 c, although shown as being attached to cup 25, maybe used for other configurations of suction members 20 disclosed hereinas well. Seal 25 c is a soft, compliant sealing gasket, which may bemade of a soft silicone, for example. Seal 25 c is molded to have a“C-shape” in cross-section, which compresses when contacted with tissue,as shown in FIG. 14B. Seal 25 c provides an excellent fluid tight sealwith the tissue even under a slight vacuum pressure. The “C” shape ofthe seal 25 c enhances its compliance, making it very effective atconforming to the shape of the surface of the tissue with which it makescontact. Although the seal 25 c is shown to be mechanically interlocked25 m with the cup 25, it may additionally, or alternatively be bonded tothe cup 25 either with glue, heat bonding, etc. Still further, seal 25 cmay be integrally molded with the cup 25 or other suction member.

FIG. 15A is a top view of another example of a suction member 20 thatmay be used as an alternate to the suction member 20 shown in FIG. 14A.In this arrangement, the suction body or cup is generally elliptical inshape as shown in FIG. 15A. Like the suction member 20 shown in FIG.14A, the suction body or cup 25 in this embodiment may be made of asilicone or other equivalent elastomer and has a foam seal or diffuser25 f around the perimeter thereof to facilitate the vacuum seal at thelocation of contact with the tissue to be grasped.

The body 25 and diffuser 25 f have compound curvature so as to formasaddle-shaped tissue contacting surface. As shown in the side view ofFIG. 15B and the sectional view of FIG. 15D, the side portions of thebottom of body 25 and of diffuser 25F curve upwardly, while the endportions of the bottom of body 25 and of diffuser 25F curve downwardly25 y as shown in the end view of FIG. 15C. Both end and side walls ofthe body 25 flare outwardly 25 w moving from top to bottom so as to forma somewhat bell-shaped body 25. This configuration aids in increasingthe depth and volume of the internal vacuum space or pocket 25 e formedby the walls of the body 25, while maintaining a smaller profile at thetop of the suction member 20 as well as focusing the vacuum flow to thecenter of the top of the body 25. This compound geometry improves theability of the suction member to engage all areas of the heart,including the apex. The deep pocket 25 e creates a large volume toengage tissue, which creates a strong engagement or hold on the tissue,while distributing the holding forces over a substantial area of thetissue so as not to damage it.

FIG. 16A shows an alternative connector for connecting a support arm 40with a suspension 30 that is both inexpensive to manufacture and easy toassembly, providing a snap fit between the components. In this example,a rigid, curved support arm 40 is shown, although the connector isapplicable to other support arms disclosed herein, such as a straightshaft, a tubular member, a flexible, multiply jointed arm etc. Clevis 32has a female connector 32 c as opposed to the male connector shown inFIG. 14A. An opening 32 o dimensioned to freely allow the insertion ofthe distal end connector 32 c is provided in the proximal end of clevis32. A retention mechanism mart be integrally molded in clevis 32 toinclude at least a pair of opposing retention members 32 m which haveinwardly extending retention hooks 32 h that approximate one another sothat they are separated by a distance that is less than the diameter “d”of retention head 42 h provided included as a portion of connector 42.Retention hooks 42 h are beveled or tapered 427 so that when connector42 is inserted, retention head 42 h abuts the tapered surfaces 42 t andthe tapered surfaces provide a mechanical advantage for the retentionbead 42 h to drive the retention hooks 32 h apart. Retention members 32m are dimensioned to have a length, thickness and width that gives thema spring constant that is sufficient to bias the retention memberstoward the positions shown in FIG. 16A.

FIG. 16B shows the tabbed appearance of a retention member 32 mseparated from the main body of clevis 32 by a channel 32 k, except forthe distal end of the retention member 32 m which is integral with theclevis body 32. In this arrangement, clevis 32 and retention members 32m are integrally molded from a polymer that has good springcharacteristics, such as polycarbonate for example. Roller 34 will snapfit into clevis 32, by slightly flexing the fork arms of the clevis andinserting pivot pins 34 p into bores 32 b.

The neck portion 42 n of connector 42 has a diameter or outsidedimension which is less than that of head 42 h, and preferably, but notnecessarily, about the same as the distance between hooks 32 h prior toinsertion of the connector 42. In this way, after head 42 h passes hooks32 h, the biasing force of the retention members 32 m forces the hooksinwardly until contacting the surfaces of neck portion 42 n. Retentionhooks 42 h are not beveled on the distal sides of the hooks andtherefore lock against the head 42 h. Suspension 30 is thereby rotatablyconnected to support arm 40, retaining the ability to rotate about thelongitudinal axis of the clevis 32 with respect to support arm 40, whilebeing prevented from detaching from the support arm by hooks 32 m.

FIG. 17A is a top view of another embodiment of a suspension 30 whicheliminates the need for biasing member 36. Clevis 32 is formed from amaterial having elastic properties (such as polycarbonate, for example)and is formed to have a relatively rigid or inflexible portion 321 and arelatively flexible portion 32 f, which is substantially along the armsof the fork or clevis 32. Thus, the arms are molded or otherwise formedto have a thickness that, given a fixed length and width, determine anappropriate flexural strength and elasticity of the flexible portion321, which functions to allow a limited amount of translation of suctionmember with respect to support arm 40 when support arm 40 is rigidlyfixed to a stationary object. 1001961 Mounting stem 24 is press fit intoroller 34, so as to maintain a fixed, relative translational positionwith respect to roller 34, as shown in FIG. 17B. In order to allowmounting stem 24 to rotate with respect to roller 34 however, a bearing34 d (FIG. 17C)is preferably press fit or otherwise fixed with respectto bore 34 b. In this arrangement, mounting stem is fixed with respectto the inside surface of the bearing 34 d upon press fitting, androtation of the bearing allows relative rotation between mounting stem24 and roller 34. When connected to a support arm by connector 32 c, andwhen an organ is grossly positioned in a retracted position by ensuringthat support arm is fixed relative to a stationary object, suspension 30allows suction member 20 to freely rotate by way of bearing 34 d, aswell as to swing by way of rotation of roller 34 with respect to clevis32. Additionally, the flexible portion 32 f of clevis 32 flexes to allowmovement of the organ and suction member in a substantiallytranslational direction along the longitudinal axis of mounting stern 24with respect to support arm 40.

A variation of the suspension 30 shown in FIGS. 17A-17B is shown inFIGS. 18A-18B. In this example, the flexible portion 32 f of clevis 32is formed from a pair of flexible wires that extend from the inflexiblebase portion 32 i. Wires 32 f may be formed from stainless steel orother biocompatible metal exhibiting a sufficient spring constant tosuspend the weight of suction member 20 attached to an organ, whilefurther allowing limited translation of the suction member and organwith respect to support arm 40. Wires 32 f are preferably molded intoinflexible portion 32 i for ease of manufacture, but could be attachedby gluing or mechanical affixation (screws, bolts or the like). Thedistal end portions of wires 32 f are formed into loops to define holes32 b into which pivot pins 34 p are inserted for mounting roller 34. Thespring like qualities of wires 32 f allow them to be flexed apartslightly to permit insertion of pins 34 p into holes 32. Afterinsertion, wires 32 f are released and they elastically return to theiroriginal positions, thereby capturing the pivot pins whereby roller 34becomes mounted to clevis 32 while retaining the ability to rotate aboutits longitudinal axis with respect to clevis 32.

The suspension 30 in FIGS. 19A and 19B operates somewhat differentlyfrom the previous two variations just described. In this example, a hook39 interconnects a support arm 40 with a shaft 24′ that is fluidlyconnected to a vacuum line as well as suction member 20. The opening oraperture 39 a of hook 39 defines a gap that is slightly shorter than theoutside diameter of shaft 24′. The inside circumference of the hook, orcircumference of the space 39 b defined inside the hook 39 is slightlygreater than the circumference of shaft 24′. Connector 32 c preferablybecomes fixed with respect to support arm 40 at least when support arm40 is rigid with respect to a stationary object.

To connect hook 39 with shaft 24′, shaft 24′ is contacted against theaperture 39 a and pressure is applied to slight spread the hook 39 open,thereby enlarging aperture 39 a sufficiently to let shaft 24′ pass intothe opening 39 b. Once the shaft 24′ is centered in opening 39 b, hook39 elastically returns to its resting configuration where aperture 39 ais slightly smaller than the diameter of shaft 24′. In this way, shaft24′ is captured within opening 39 b, but not so tightly as to preventfree rotation of shaft 24′ within opening 39 b. Connector 38 has adiameter greater than the inner circumference 39 b of hook 39 and thusacts as an upper stop to prevent hook 39 from sliding upward withrespect to shaft 24′. Additionally, a lower stop 24 s which also has adiameter or outer dimension greater than the inner circumference 39 b ofhook 39 is provided to act as a lower stop to prevent hook 39 fromsliding downward with respect to shaft 24′. The gap defined betweenupper and lower stops 38 and 24 s may be slightly greater than thethickness of hook 39 to facilitate easier connection of the components.However, the gap should not be so large as to allow an inordinate amountof “free play” in the connection. The connection tube 24 e extendingfrom lower stop 24 s and fluidly connecting the distal portion of thesuction member to shaft 24′ is preferably formed of a soft silicone orother highly elastic material. When assembled, the suspension in thisexample allows rotation of the suction member 20 With respect to thesupport arm 40 by the free rotation of the shaft 24′ that is allowedwith respect to hook 39. Elastic tube 24 e allows limited amounts oftranslation of the suction member and organ with respect to the supportarm 40, as well as allowing swinging motions of the type that roller 34allows as well as the type that would be allowed by rotation ofconnector 32 c in previous embodiments with respect to support arm 40.

An additional advantageous feature provided by suspensions 30 of thetype demonstrated in FIGS. 19A and 19B is the ability to attach suctionmember 20 to an organ prior to connecting hook 39 to shaft 24′. Thisallows more working space for retracting the organ, Which may also begrossly positioned prior to connecting hook 39. Thus, suction member canbe positioned as desired on an organ to be retracted, and then suctioncan be applied to fix the position of suction member on the tissuesurface of the organ to be retracted. Next the organ can be grosslypositioned in a retracted position by manipulating suction member 20 topull the organ to the desired gross position. Once grossly positioned,hook 39 is attached to shaft 24′ as described above, and support arm 40is fixed in position, so as to maintain the organ in the desired grossposition without further manual assistance.

The organ manipulator shown in FIG. 20 conceals vacuum line 7 withinsupport arm 40, which is, in this example, a substantially rigid tubularmember, made of aluminum or stainless steel, or rigid polymer, forexample, which may be straight or curved. A multi-link support arm mayalso be configured in the manner shown in FIG. 20. A curved tubularmember 40 provided additional maneuverability of the device. However, astraight tubular member 40 may also be used in intercostal and possiblyendoscopic deliveries, depending upon the size and configuration of thesuction member 20. The suspension 30 in this arrangement is compact,which is especially important for intercostal and endoscopic deliveries,and includes a thin, highly elastic tubing 24 e. The thickness of tubing24 e can be varied to design a suspension having the appropriate springrate for the mass of the organ to be retracted. The cup portion ofsuction member 20, tubing 24 e and tubing 7 may all be integrally moldedin this embodiment. A spring 24 k is preferably threaded within thelumen of tubing 24 e to prevent kinking of the tubing 24 e duringbending. With this arrangement, only a limited amount of rotation ofsuction member with respect to support arm 40 is allowed by suspension30.

FIG. 21 shows a variation of the organ manipulator 10 of FIG. 20. InFIG. 21. spring 24 k is mounted externally over tubing 24 e and againfunctions to prevent kinking of tubing 24 e during bending. Thisarrangement facilitates the use of a smaller diameter tubing 24 e thatmay lessen the resistance to rotation of the suction member with regardto support arm 40. However, the external spring 24 k may be slightlymore of an obstruction for use intercostally or endoscopically. Onceagain, however, vacuum line 7 has been integrated within support arm 40thereby significantly reducing tile profile of the organ manipulationdevice 10 and allowing the surgeon adding working space andvisualization of the surgical site.

The organ manipulator shown in FIG. 22 combines the vacuum tubingintegration function with a suspension 30 of the type described in FIGS.17A-17B. In this arrangement, a loop of tubing 7 is provided between itsconnection to shaft 24 and where it enters support arm 40 so as not toprovide additional resistance to translatory movements of the suctionmember 20 with respect to support arm 40. A slot, opening or hole 40 ais provided in support arm 40 through which tubing 7 enters. Tubing 7exits support arm 40 at the proximal end thereof. Preferably, a spring24 k is provided inside tubing 7 along at least the loop portion thereofand preferably along the full length of the organ manipulator, toprevent kinking. Clevis 32 is rotatabl) mounted to support arm 40 toallow rotation of clevis 32 about the longitudinal axis of support arm40 with respect to support arm 40. Roller 34 allows swinging of suctionmember 20 with respect to support arm 40 and the arms of clevis 32 areflexible to allow

FIG. 23 shows an additional arrangement for integrating vacuum tubing 7even more completely within the organ manipulation device in whichtubing 7 exits through an opening 32 o in clevis 32. Support arm may bejoined to clevis 32 as described with regard to FIG. 16A oralternatively may be glued or bonded thereto, although this option wouldeliminate the freedom of the clevis to rotate with respect to supportarm 40. Tubing 7 passes through the proximal end of support arm 40 asdescribed and shown previously (not shown in FIG. 23), passes throughthe distal end of support arm into clevis 32 and out of opening 32 o.Tubing 7 connects at its distal end to connector 38. The portion oftubing 7 that is external to the device is pleated or accordioned toallow it to assume the S-shape as shown in FIG. 23 without kinking,cracking or other problems. Additionally, the pleated tubing moves withthe shaft 24 more reliably without any of the aforementioned problems,and with less resistance to free movements of the shaft 24 than astandard tubing, which is less flexible and therefore more resistant tosuch movements.

A further modification of the organ manipulation device eliminates theneed for tubing 7 altogether, as shown in FIG. 24. In this arrangement,a curved or straight substantially rigid tube 40 is directly connectedat its proximal end to a vacuum line leading to a source of vacuum. Therigid tube 40 is leak proof and delivers the v vacuum from its proximalend to suspension 30. Suspension 30 is of a modified ball and socketconstruction, with the socket component 302 being of two piececonstruction, having an upper portion 302 a and a lower portion 302 b.The upper and lower portions are brought together on opposite sides ofball 304 to encapsulate it and provide bearing surfaces against whichthe ball 304 can rotate. The upper and lower portions 302 a, 302 b areclamped bolted or otherwise compressed together to form an airtight sealwith the assistance of O-rings 302 c. The upper and lower portions 302a, 302 b by this action also tightly clamp support arm 40 so that atleast free rotation between support arm 40 and suspension 30 is notpossible. The assembled socket component 302 further defines an annularspace surrounding ball 304 to ensure that the flow path of the vacuum isnot interrupted through a 360 degree rotation of the ball 304 in thehorizontal plane.

Ball 304 is provided with a wedge shaped cut out 304 a that mates withannular space 302 d for fluid connection between the ball 304 and socket302. The angle a of wedge is at least as great as the angle defining themaximum amount of swing that suction member can rotate about an axisperpendicular to the page on which FIG. 24 appears. This ensures thatfluid contact will not be broken even when the suction member swings bya maximum amount, regardless of the amount of rotation in the horizontalplane that has occurred in the ball. Connecting shaft 24 is providedwith a slot 24 j or other opening that fluidly connects the suctionmember 20 with the suspension 30. Shaft 24 is freely rotatable withrespect to ball 304 about the longitudinal axis of shaft 24. A biasingmember 36 (such as a coil spring. for example) is provided between upperstop 24 h and ball 304 to allow a limited amount of translation of thesuction member 20 With respect to ball 304 and to return the suctionmember and organ to a desired position of the shaft 24 with regard toball 304.

The organ manipulation apparatus shown in FIG. 25 not only eliminatesthe need for a vacuum tubing to be run all the way to the site of thesuspension (since support arm 40 carries out the function), but allowsplacement of the suction member against an organ to be manipulated,prior to attaching the support arm. This configuration is particularlyadapted for an intercostal or endoscopic delivery of the support arm 40.Suction member 20 may be introduced against the surface of the heart,for example, after having been inserted through another opening, such asa sub-xyphoid incision, for example. Support arm 40 may next be insertedthrough an intercostal incision in line with the placed suction member20. A substantially rigid support arm 40 aids in intercostal penetrationas well as in connecting the support arm to quick connector 306.Generally, support arm 40 will have a length between about two and eightinches and an outer diameter between about ⅛^(th) and 5/16^(th) of aninch. Preferably, its diameter matches that of suction line 7. Aflexible elastic tubing 24 e is preferably used to fluidly connect thequick connector 306 to the suction member to allow flexion close to theheart surface. The distal end portion of support arm 40 is provided withannular grooves 40 g which are captured by annular protrusions 306 awithin quick connector 306, thereby preventing disconnection between themembers while at the same time allowing axial rotation of the suctionmember 24, organ and quick connector 306 with respect to support arm 40.In addition, tube 24 e man be adapted to twist or flex to accommodateorgan motion.

A binding member 402 such as a binding ring may be provided to fix aposition of the device 10 with respect to the location of insertion ofsupport arm 40. to prevent any further insertion of the tubing into thepatient. For example, in an intercostal delivery of support arm 40,binding ring 402 is abutted against the ribs 404,406 between whichsupport arm has been inserted. Prior to connecting up support arm 40with quick connector 306, the binding leg 402 a is maintainedsubstantially in parallel with the main body 402 b of the binding ring402 so that tubing 7 is allowed to slide freely through an opening inbinding leg 402 a. Once support arm has been properly connected and thusthe organ manipulation apparatus is positioned as desired, binding leg402 a is flexed or canted to the locked or frictional position shown inFIG. 26B such that a large amount of force (i.e., a force significantlygreater than any forces imposed by the beating heart against the device)is required to overcome the friction imposed by the angled leg 402 aagainst the tubing 7, to move the tubing any further inward into thepatient (in the direction of the arrow shown in FIG. 26B).

FIGS. 27A-27E show another example of an organ manipulation apparatus,in various stages of assembly, that may be used to retract an organprior to mounting to a support arm. Assembly of suction member 20 tosuction tube 7 is precluded by sliding a biasing member 36, such as acoil spring, for example, over connecting shaft 24 and then insertingshaft 24 into tube 7 to form an air tight seal either through a frictionfit or by gluing or the like. Additionally, the top end of biasingmember 36 may be glued to tube 7 in order to facilitate connection ofroller 34 to shaft 24, described below. In any case, the outsidediameter of tube 7 is greater than that of biasing member 36, so thatthe distal end of tubing 7 acts as a stop member against which theproximal end of biasing member 36 abuts.

Biasing member 36 function in conjunction with clevis 32 and roller 34as the suspension 30 in this arrangement. Clevis 32 is substantiallyinflexible since biasing member 36 allows limited translator movement ofsuction member 20 with respect to support arm 40. Roller 34 isconfigured and functions similarly to previously described rollers 34except that hole 34 b has an opening or aperture 39 a that enablesconnection of the support arm to the suction member subsequently toplacement of the suction member against the tissue of the organ to beretracted, application of suction to Grasp the tissue, and retraction ofthe organ. Similar to the embodiment of FIGS. 19A and 19B, aperture 39 aof roller 34 defines a gap that is slightly shorter than the outsidediameter of shaft 24. The circumference of the hole 34 b, however, isslightly greater than the circumference of shaft 24. Connector 32 c isrotatably connected to support arm 40, so that clevis 32 can rotateabout the longitudinal axis of support arm 40 with respect to supportarm 40 after connection thereto. Roller 34 can also axially rotate withrespect to levis 32.

To connect roller 34 with shaft 24, roller 34 is approximated with shaft24 by manipulating support arm to bring the roller into contact withshaft 24, as shown in FIGS. 27D-27E. Pressure is applied such that thebeveled aperture 39 a slightly squeezes shaft 24 so that it becomesmomentarily slightly oval in cross section, just enough for it tosqueeze through the aperture 39 a. Upon entering and centering itself inhole 34 b, shaft 24 resumes it circular cross section and is free torotate with respect to the roller 34. Roller 34 is mounted onto shaft 24distally to biasing member 36, which abuts against roller 34 as a lowerstop.

Support arm

As noted above, the organ manipulation devices according to the presentinvention may use a variety of different types of support armsincluding, but not limited to solid, substantially rigid straight orcurved members, curved or straight tubular members and multi-jointedmembers, such as those shown in FIGS. 1A and 1B. for example. A primaryfunction of any support arm used is to provide a substantiallystationary support for maintaining gross positioning of a retractedorgan. A suspension as described herein then connects a suction memberto the support arm in a manner which allows some movements of the organattached to the suction member, while maintaining the organ in the samegross position.

FIGS. 28A-28E show variations of depressible disks and balls (FIG. 28B)that may be used to construct a support arm 40 as shown in FIG. 1A.Since the working space provided by the incision opening is quitelimited, it is desirable to make the organ manipulation device 10 assmall and low profile as possible to maintain maximum working space, aswell as visibility for the surgeon. The device shown in FIG. 1A includesa low profile mount 44 which is connected at a proximal end portion ofthe support arm 40. The mount includes a first mount portion and asecond mount portion, which is pivotally connected to the first mountportion, as shown and described in co-pending application Ser. No.09/769,904. The first mount portion may be integral with a malearticulating surface of a rotational joint that it then forms a part ofat the proximal end of the support arm 40. The second mount portion ispivotal away from the first mount portion to position the mount over afixed object, such as rail 418 or crossbar 5 to release the mount fromthe fixed object. The mount portion also allows the organ manipulationapparatus 10 to be slid along rail 418 to which it is mounted. Thesecond mount portion is pivotable toward the first mount portion to fixthe mount on the fixed object.

The mount 44 may further comprise a locking mechanism adapted to lockthe second mount portion to the first mount portion in a closed positionupon pivoting the second mount portion toward the first mount portion.The closed position is configured to lock the mount on the fixed object.The fixed object may be a sternal retractor, for example, or otherobject, which is stationary relative to the moving tissue. The mountportions may each further include a rail grip adapted to engage one sideof a rail 418 on a sternal retractor. The locking mechanism may includea living hinge formed in one of the first and second mount portions anda pin extending transversely on the other of the first and second mountportions, the pin being adapted to snap fit into the living hinge.

A cable passes internally through each of the articulating joints formedby depression disks 46 and balls 48 and mount 44. The cable is furtherattached to a tensioning mechanism proximally of the mount 44. Thetensioning mechanism may include a screw mechanism and a knob. The screwmechanism has a first threaded component having a first set of threadsand a second threaded component having a second set of threads adaptedto mate with the first set of threads. The first threaded component isfixed to the cable and the knob is adapted to torque the second threadedcomponent with respect to the first threaded component. The screwmechanism is adapted to lock the first and second mount portionstogether in the closed position, to securely lock the organ manipulationapparatus 10 on the rail 418, crossbar 5 or other stationary object onwhich it is mounted.

The second threaded component may include a torque limiter having aunidirectional slip clutch, which is engageable with the knob 50. Theknob 50 positively engages the torque limiter for unthreading the secondset of threads from the first set of threads, and positively engages thetorque limiter for threading the second set of threads on the first setof threads until a predetermined amount of torque is required to furthertension the cable. Upon reaching the predetermined amount of torqueduring threading, the torque limiter slips with respect to the knob.

The slip clutch may include at least one fin extending from an outersurface of the second threaded member at an angle to a line normal to atangent line passing through the location from which the fin extends.Each fin is adapted to engage a groove formed in an inner surface of theknob.

The cable includes a stop member fixed to a distal end thereof, suchthat, upon applying tension to the cable with the tensioning member, thestop member and the tensioning member apply a compressive force to themount 44, depression disks 46 and balls 48, thereby locking every jointinto an assumed orientation.

A coupling mechanism which links the stop member to the connector 32 c,thereby also linking the support arm 40 to the suspension 30, is furtherprovided. The coupling member may be adapted to lock the connector 32 cabsolutely, or alternatively to capture the connector 32 c while stillallowing it to rotate with respect to the support arm 40, when the cableis placed under a sufficient tension to lock the maneuverable arm. Thecoupling mechanism may include a socket member rotatably joined with thestop member and adapted to receive the ball of connector 32 c to form aball joint. The socket member may further include a slot through a sidewall thereof, which terminates in an enlarged opening dimensioned topermit the ball member to pass therethrough. The coupling mechanism mayfurther include a coupling link having arms adapted to lock with thesocket member, and an upper abutment surface adapted to abut the stopmember. A second coupling link having driving surfaces adapted tocontact a distal most link of a distal most articulating joint of themaneuverable arm may also be provided. The second coupling link mayfurther include a lower abutment surface adapted to abut an upperportion of the ball member, wherein, upon tensioning of the cable, thestop member draws the first coupling link and the socket member in aproximal direction, whereby the socket member compresses the ball memberagainst the lower abutment surface. Optionally, a flexible sleeve mallbe positioned over the articulating joints of the support arm 40.

Depression disks 46 are threaded over the cable in an alternating serieswith balls 48. The depression disks 46 are made of a material which isharder than the material from which balls 48 are made. Depression diskshave concave surfaces on both sides and are provided with features thatare designed to deform portions of abutting balls 48 on either side whenthe disks 46 and balls 48 are compressed together as the cable istensioned. This deformation enhances the locking function between eachball and disk, as it is much more difficult to rotate the interlockingsurfaces when they are not uniformly spherical. When the tension isreleased from the cable, the support arm goes from a locked state to amalleable state again as the disks and balls are allowed to separatefrom one another again, thereby freeing them up to move with respect toone another along the articulating joints. The deformations on the ballsalso relax when the balls 48 separate from compression by the disks 46,as they are generally made of polymers which are only elasticallydeformed during the compression/locking phase.

The depression disk 46 shown in FIG. 28A includes grooves or recesses 46b which allow the abutting ball 48 to become partially embedded thereinduring compression due to the tensioning of the cable. FIG. 28B shows anexample of a ball 48 which is the basic configuration for use with allof the variations of depression disk 46 shown. Each ball has a conicallyshaped void 48 a formed therein that allows angulation of thearticulating joint formed between ball 48 and disk 46, by relativerotation of their mating surfaces, without deflecting the cable whichruns through both components, thereby maintaining the amount of tensionin the cable existing before the articulation. Exemplary material pairsthat math be used for the ball 48 and disk 46 to ensure that the diskmaterial is harder than the ball material include: machinedpolycarbonate ball with machined Ultem disk; molded Isoplast ball withmolded polycarbonate/Teflon glass disk; and molded polycarbonate ballwith molded Ultem disk.

The depression disk 46 shown in FIG. 28C includes protrusions 46 c whichdig into the abutting ball 48 and form depressions therein, therebybecome partially embedded in the ball during compression due to thetensioning of the cable. The protrusion features 46 c act as graspingfeatures that, upon digging into the surface of the ball 48, increasethe force required to deflect the support arm 40 over that required ofan arm that is fixed based only on friction between the concave surfacesof the disks and convex surfaces of the balls, thereby increasing therigidity of support arm 40 in the locked or compressed state. In bothdisk variants of FIGS. 28A and 28C, the radially oriented features 46b/46 c provide increased resistance to rotational failure of the lockingbetween articulating joint surfaces.

The depression disk 46 shown in FIG. 28D includes circumferentiallyoriented protrusions 46 d which dig into the abutting ball 48 and formdepressions therein, thereby become partially embedded in the ballduring compression due to the tensioning of the cable. The protrusionfeatures 46 d act as grasping features that, upon digging into thesurface of the ball 48, increase the force required to deflect thesupport arm 40 over that required of an arm that is fixed based only onfriction between the concave surfaces of the disks and convex surfacesof the balls, thereby increasing the rigidity of support arm 40 in thelocked or compressed state. Circumferentially oriented protrusions 46 dare radially spaced from each other and provide resistance to rotationalfailure in a direction normal to that of the resistance provided by thetwo previously discussed configurations. The resistance provided in thisembodiment is in a direction against the tendency of a support arm 40 tosag due to gravitational forces, especially at the distal end of the armthat is not fixed to a stationary object. It is further noted thatvarious combinations of the features shown in FIGS. 28A, 28C and 28D maybe employed in a depression disk. For example, a depression disk mayinclude circumferentially oriented protrusions 46 d with radiallyoriented recesses 46 b. Still further, a depression disk may be formedto have circumferentially oriented recesses.

The depression disk 46 shown in FIG. 28E is formed of two differentmaterials. The material 46 e located in the more central portion of thedisk and concave surface 46 a is relatively softer that the material 46f located radially outward thereof, on the outer portion of the concavesurface 46 a and depression disk 46. The harder material 46 f providesstructural support for the disk 46. The softer material 46 e, althoughhaving a generally concave surface, extends outwardly slightly from theconcave surface of the harder material 46 f, thereby forming a step ordiscontinuity where the two materials meet at 46 g. When the cable isplaced under tension to compress the disk and ball components together,ball 48 compresses the soft material 46 e until ball 48 contacts theharder surface 46 f. By compressing the softer material 46 e, a better,more conforming surface contact with the ball 48 is achieved, therebyincreasing the level of friction between surface 46 e and ball 48 andbetween ball 48 and disk 46 overall. The result is increased rigidity ofthe support arm 40 I the locked state, as compared to a conventionalball and disk arrangement. The soft material 46 e must be softer thanthe material of the ball 48, while the hard material may be of the samehardness as the ball. It is further noted that various combinations ofthe features shown in FIGS. 28A, 28C and 28 D may be employed in adepression disk that also includes the features described with regard toFIG. 28E. For example, a depression disk may include circumferentiallyoriented protrusions 46 d on the surface 46 f.

While the present invention has been described with reference to thespecific embodiments thereof, it should be understood by those skilledin the art that various changes may be made and equivalents may besubstituted without departing from the true spirit and scope of theinvention. Just as an example, it is noted that an organ manipulationdevice, such as shown in FIG. 1 could be modified to replace theconnector 44 with a connector 142 of the type shown in FIG. 1 withoutdeparting from the true spirit and scope of the invention, and this isonly one example, as many such substitutions or modifications arecontemplated. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processstep or steps, to the objective, spirit and scope of the presentinvention. All such modifications are intended to be within the scope ofthe claims appended hereto.

1. An organ manipulation apparatus comprising: a suction memberconfigured to exert sufficient force on an organ to move the organ whenthe suction member is placed against the organ, a relative negativepressure is established in a space between the suction member and theorgan, and the suction member is moved; a support structure adapted tobe substantially rigidly fixed to a relatively immovable object; and asuspension interconnecting said suction member and said supportstructure, said suspension allowing at least a limited amount ofrotation of said suction member with respect to said support member toaccommodate natural movements of the organ.
 2. The apparatus of claim 1wherein said suspension further allows a limited amount of translationof said suction member, along an axis of said suction member, withrespect to said support structure.
 3. The apparatus of claim 1, whereinsaid suction member comprises a substantially rigid shaft extendingtherefrom, and said suspension comprises a roller rotatably mounted in abase member, said roller having an axis of rotation and a boresubstantially perpendicular to said axis of rotation, said substantiallyrigid shaft being mounted in said bore. 4-17. (canceled)
 18. Theapparatus of claim 1, wherein said suspension comprises an elastomerictubular member extending from said suction member and adapted to beconnected with said support structure. 19-23. (canceled)
 24. Theapparatus of claim 1, wherein a flexible tubular member extends fromsaid suction member and is adapted to fluidly connect said suctionmember with a source of vacuum, said support structure comprising asubstantially rigid tubular member, said flexible tubular member passingthrough said rigid tubular member, and a spring mounted over a portionof said flexible tubular member between said suction member and saidsubstantially rigid tubular member. 25-28. (canceled)
 29. The apparatusof claim 1, wherein said support structure comprises a substantiallyrigid tubular arm, said suction member comprises a substantially rigidtubular member extending therefrom, and said suspension comprises a ballhaving a first passage therethrough and a socket partially constrainingsaid ball but allowing rotation thereof with respect to said socket,said substantially rigid tubular member passing through said firstpassage, said ball and socket fluidly connecting said suction memberwith said substantially rigid arm via an opening in said substantiallyrigid tubular member. 30-32. (canceled)
 33. The apparatus of claim 1,wherein the support structure includes an articulating arm have aflexible state and a rigid state, said articulating arm comprising acable; a plurality of depression disks and balls alternatively threadedover said cable, each of said depression disks having a pair of concavesurfaces adapted to engage a pair of said balls; and a tensioningmechanism adapted to apply tension to said cable, wherein said balls andcompression disks are compressed against one another upon application oftension to said cable and said articulating arm assumes said rigidstate. 34-40. (canceled)
 41. The apparatus of claim 1, wherein saidsuction member comprises a foam cup, said foam cup having an insidesurface and an outside skinned surface, a periphery of said cup beingfolded over so that the skinned surface is adapted to contact an organand form a seal therewith.
 42. (canceled)
 43. The apparatus of claim 1,wherein said suction member comprises a silicone cup having an innerlining of open cell foam, wherein said inner lining further comprises askin at a periphery thereof, said skin adapted to contact an organ andform a seal therewith.
 44. The apparatus of claim 1, wherein saidsuction member comprises a cup having internal grooves adapted to applynegative pressure to a surface of an organ even if the organ is suckedinside said cup to contact an inner surface thereof.
 45. The apparatusof claim 1, wherein said suction member comprises a cup having an innersurface and an outer surface, and an organ restraint member adapted torestrain an organ from contacting said inner surface, said organrestraint member and said inner surface defining a vacuum baffle chambertherebetween. 46-49. (canceled)
 50. The apparatus of claim 1, whereinsaid suction member comprises a first layer made of an air impermeablematerial and having an inside surface and an outside surface, said firstlayer having holes therethrough for directing air flow therethrough; afirst foam layer adjacent said inside surface; a second foam layeradjacent said outside surface; a tube in fluid connection with saidsecond foam layer; and a second layer made of an impermeable materialand sealing said tube and second foam layer with said first layer madeof an impermeable material. 51-55. (canceled)
 56. The apparatus of claim1, wherein said suction member comprises an air impermeable layer havingan inner surface and an outer surface, said air impermeable layer havingat least one opening therethrough fluidly connecting a vacuum tube tosaid inner surface, and a foam donut adjacent said inner surface andsurrounding each said vacuum tube.
 57. The apparatus of claim 1, whereinsaid suction member comprises an air impermeable cup and a telescopingsoft sleeve having a retracted position and an extended position,wherein said telescoping soft sleeve is biased toward said extendedposition.
 58. (canceled)
 59. The apparatus of claim 1, wherein saidsuction member comprises a pleated cup.
 60. The apparatus of claim 1,wherein said suction member comprises a compliant seal around aperimeter thereof, said compliant seal being substantially C-shaped incross section and deformable to conform to the shape of a surface of anorgan upon contact therewith.
 61. The apparatus of claim 1, wherein saidsuction member comprises a compliant seal within a perimeter thereof,said compliant seal being a substantially flat flange and deformable toconform to the shape of a surface of an organ upon contact therewith.62-63. (canceled)
 64. The apparatus of claim 1, wherein said suctionmember comprises a saddle-shaped tissue contact surface.
 65. Theapparatus of claim 1, wherein said suction member is ellipticallyshaped.
 66. The apparatus of claim 1, wherein said suction member isoval-shaped.
 67. The apparatus of claim 1, wherein said suction membercomprises a tissue contact surface, and at least a portion of saidtissue contact surface is curved or non-planar.
 67. An organmanipulation apparatus comprising: a suction member configured to exertsufficient force on an organ to move the organ when the suction memberis placed against the organ, a relative negative pressure is establishedin a space between the suction member and the organ, and the suctionmember is moved; a support structure adapted to be inserted through asmall opening in a body of a patient; a coupling member into which saidsupport structure is fitted after insertion of said support structurethrough the small opening; and a flexible suspension interconnectingsaid suction member and said coupling member.
 68. (canceled)
 69. Theapparatus of claim 67, wherein said flexible suspension comprises aflexible tubular member that allows a limited amount of translation ofsaid suction member along an axis of said suction member, with respectto said support structure. 70-73. (canceled)
 74. The apparatus of claim67, further comprising a binding member adapted to prevent advancementof said support structure further into the body once the supportstructure has been positioned as desired. 75-76. (canceled)
 77. Asurgical method performed on a beating heart comprising the steps of:applying a suction member of a manipulation device to a surface of theheart; creating suction between the suction member and surface of theheart; moving the suction member to retract the heart into a positionthat provides access to a surgical site that would be difficult orimpossible to access without retraction; connecting the suction memberwith a compliance mechanism attached to a support arm; and fixing thesupport arm with respect to a stationary object, wherein the compliancemechanism permits at least limited translation of the heart and suctionmember with respect to the support arm.
 78. (canceled)
 79. The method ofclaim 77, further comprising the steps of: contacting a surgical targetarea on the heart with a stabilizer in the vicinity of the surgicaltarget to stabilize the surgical target; and performing a surgicalprocedure on the surgical target. 80-82. (canceled)
 83. A surgicalmethod performed on a beating heart comprising the steps of providing amanipulation device having a suction member, a support arm, and acompliance mechanism interconnecting the suction member and support armand permitting at least limited translation and rotation of the suctionmember with respect to the support arm; applying the suction member ofthe manipulation device to a surface of the heart; creating suctionbetween the suction member and surface of the heart; moving the suctionmember to retract the heart into a position that provides access to asurgical site that would be difficult or impossible to access withoutretraction; and fixing the support arm with respect to a stationaryobject, wherein the compliance mechanism permits at least limitedtranslation and rotation of the heart and suction member with respect tothe support arm. 84-87. (canceled)
 88. A surgical method performed on abeating heart comprising the steps of: providing a manipulation devicehaving a suction member, a support arm, and a suspension interconnectingthe suction member and support arm and permitting at least limitedmovement of the suction member with respect to the support arm;accessing the beating heart of a patient; contacting the suction memberof the manipulation device to a surface of the heart; creating suctionbetween the suction member and surface of the heart so that the suctionmember grasps the surface of the heart; moving the suction member toretract the heart into a position that provides access to a surgicalsite that would be difficult or impossible to access without retraction;contacting tissue of the heart at or near the surgical site with astabilizer and stabilizing the surgical site; and performing a surgicalprocedure at the surgical site. 89-94. (canceled)
 95. A surgical methodperformed on a beating heart comprising the steps of: accessing thebeating heart of a patient; contacting a suction member of an organmanipulation device to a surface of the heart; creating suction betweenthe suction member and surface of the heart so that the suction membergrasps the surface of the heart; moving the suction member to retractthe heart into a position that provides access to a surgical site thatwould be difficult or impossible to access without retraction;contacting tissue of the heart at or near the surgical site with astabilizer and stabilizing the surgical site; and performing a surgicalprocedure at the surgical site. 96-97. (canceled)
 98. A system forperforming beating heart coronary artery bypass grafting, said systemcomprising: an organ manipulation device having a suction memberconfigured to exert sufficient force on the beating heart to move thebeating heart when the suction member is placed against a surface of theheart, a relative negative pressure is established in a space betweenthe suction member and the heart, and the suction member is moved; asupport structure adapted to be substantially rigidly fixed to arelatively immovable object; and a suspension interconnecting saidsuction member and said support structure, said suspension allowing atleast a limited amount of rotation of said suction member with respectto said support member to accommodate natural movements of the beatingheart; a stabilizer device having at least one contact member adapted tocontact the surface of the beating heart at or adjacent a location wherean anastomosis is to be performed; and a sternal retractor, wherein saidsupport arm and said stabilizer are adapted to be fixed to said sternalretractor.
 99. (canceled)
 100. A system for performing beating heartcoronary artery bypass grafting, said system comprising: an organmanipulation device having a suction member configured to exertsufficient force on the beating heart to move the beating heart when thesuction member is placed against a surface of the heart, a relativenegative pressure is established in a space between the suction memberand the heart, and the suction member is moved; a support structureadapted to be substantially rigidly fixed to a relatively immovableobject; and a suspension interconnecting said suction member and saidsupport structure, said suspension allowing at least a limited amount ofrotation of said suction member with respect to said support member toaccommodate natural movements of the beating heart; and a stabilizerdevice having at least one contact member adapted to contact the surfaceof the beating heart at or adjacent a location where an anastomosis isto be performed.
 101. (canceled)